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Combination Products, Orphan Drugs, and OTC Drugs

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Presentation to the San Diego Regulatory Affairs Network (SDRAN) Regulatory Affairs Certification (RAC) Exam review course on FDA regulation of combination products, orphan drugs, and OTC drugs.

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Combination Products, Orphan Drugs, and OTC Drugs

  1. 1. Solving FDA Legal Challenges for the Life of a Life Sciences Company -1- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT Combination Products, Orphan Drugs and OTC Drugs SDRAN RAC Review Course July 26, 2018 Michael A. Swit, Esq.
  2. 2. Solving FDA Legal Challenges for the Life of a Life Sciences Company -2- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT Standard Disclaimers ➢ Views expressed here are solely mine and do not reflect those of my law firm or any of its clients. ➢ This presentation supports an oral briefing and should not be relied upon solely on its own to support any conclusion of law or fact. ➢ These slides are intended to provide general educational information and are not intended to convey legal advice.
  3. 3. Solving FDA Legal Challenges for the Life of a Life Sciences Company -3- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT Our Topics Today ➢ Combination Products ➢ OTC Drugs ➢ Orphan Drugs 3
  4. 4. Solving FDA Legal Challenges for the Life of a Life Sciences Company -4- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT COMBINATION PRODUCTS 4
  5. 5. Solving FDA Legal Challenges for the Life of a Life Sciences Company -5- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ A Brief History of Combination Product Regulation ➢ Primary Mode of Action (PMOA) – The Key Lynchpin to FDA’s Regulatory Regime for Combination Products ➢ The Request for Designation (RFD) Process ➢ GMPs ➢ Post-Market Safety Reporting ➢ How Many Applications to File? ➢ User Fees What We Will Cover 5
  6. 6. Solving FDA Legal Challenges for the Life of a Life Sciences Company -6- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ As defined in 21 CFR § 3.2(e), the term combination product includes: ➢ A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity; ➢ Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products; ➢ A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or ➢ Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect. What Is a Combination Product? 6
  7. 7. Solving FDA Legal Challenges for the Life of a Life Sciences Company -7- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT The Combination Galaxy Devices  PMA/510(k)/ IDE  QSR  MDR Drugs NDA/IND cGMP AERS Biologics BLA/IND cGMP+ AERS+ Primary Mode of Action Consultation Regulations
  8. 8. Solving FDA Legal Challenges for the Life of a Life Sciences Company -8- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Safe Medical Device Act of 1990 -- combination products first statutorily recognized – Required assignment to lead center based on Primary Mode of Action (“PMOA”) – Implemented by Chief Mediator and Ombudsman ➢ Office of Combination Products (“OCP”) – Created by Medical Device User Fee and Modernization Act (MDUFMA) – 2002 – OCP given broad oversight responsibilities covering the regulatory life cycle of combination products. • Coordinate reviews among FDA Centers • Ensure consistency among similar reviews A Brief History of Combinations 8
  9. 9. Solving FDA Legal Challenges for the Life of a Life Sciences Company -9- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT 9 Section 503(g) of the Act ➢ FDA is required to assign a combination product to a lead Center based on its "primary mode of action" ➢ PMOA was not defined in the statute or regulations ➢ For some products, PMOA is difficult to identify – Early in development (just don't know) – Products that have two (or more) completely different modes of action, neither of which is subordinate to other
  10. 10. Solving FDA Legal Challenges for the Life of a Life Sciences Company -10- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ PMOA = Primary Mode of Action; originally not defined in statute, but in regulations. – Final Rule – 8/25/2005; 70 Fed. Reg. 49848 – Cures Act (2016) – added statutory definition into Section 503(g) of Act ➢ Mode of Action: the means by which a product achieves an intended therapeutic effect or action 21 CFR 3.2(k) PMOA -- Determining Which Center Leads 1 0
  11. 11. Solving FDA Legal Challenges for the Life of a Life Sciences Company -11- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Primary mode of action -- 503(g)(1)(C) of Act – “For purposes of this subsection, the term "primary mode of action" means the single mode of action of a combination product expected to make the greatest contribution to the overall intended therapeutic effects of the combination product.” ➢ Three types of modes of action: – Biological product – Device – Drug ➢ Combination products typically have more than one identifiable mode of action Source: 21 CFR 3.2(m) PMOA … 1 1
  12. 12. Solving FDA Legal Challenges for the Life of a Life Sciences Company -12- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ A constituent part of a combination product has a: – Biological product mode of action if it acts by means of a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the prevention, treatment, or cure of a disease or condition of human beings… – Device mode of action if it meets the definition of device…, it does not have a biological product mode of action, and it does not achieve its primary intended purposes through chemical action within or on the body….and is not dependent on being metabolized for the achievement of its primary intended purposes – Drug mode of action if it meets the definition of drug…and it does not have a biological product or device mode of action. Constituent Parts 1 2
  13. 13. Solving FDA Legal Challenges for the Life of a Life Sciences Company -13- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Proposed use(s) or indication(s) ➢ How it achieves its overall intended therapeutic effect(s) – Cures Act clarification – 503(g)(1)(E) – “In determining the primary mode of action of a combination product, the Secretary shall not determine that the primary mode of action is that of a drug or biological product solely because the combination product has any chemical action within or on the human body.” • Reason – a device might trigger chemical responses, but may not be used to determine if that is not its primary intended purpose ➢ Relative contribution of each component toward the overall intended therapeutic effect ➢ Duration of the contribution of each component towards the intended therapeutic effect ➢ Data or information that describes and supports the mode of action Factors Impacting PMOA 1 3
  14. 14. Solving FDA Legal Challenges for the Life of a Life Sciences Company -14- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ If unable to determine most important therapeutic action with reasonable certainty, FDA will use the “assignment algorithm” at 21 CFR 3.4(b). ➢ Two major factors, considered in order: – Consistency: is there an agency component that regulates other combination products presenting similar questions of S & E with regard to the combination product as a whole? – Safety and Effectiveness: which agency component has the most expertise related to the most significant S&E questions presented by the combination product? The PMOA Decision Tree – “Assignment Algorithm” 1 4
  15. 15. Solving FDA Legal Challenges for the Life of a Life Sciences Company -15- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Intended use/indication(s) ➢ Overall therapeutic effect(s) ➢ Does a device component incorporate a novel or complex design or have potential for significant failure modes? ➢ Is drug component a new molecular entity or formulation? ➢ Has a generic version of drug been approved? ➢ Is biological component a particularly fragile molecule? Assignment Algorithm – Additional Factors 1 5
  16. 16. Solving FDA Legal Challenges for the Life of a Life Sciences Company -16- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ How well understood are the components on a comparable basis? Is one more risky? ➢ Which components raise greater risks? ➢ Have any components been approved/cleared? ➢ Is there a new indication, route of administration, or significant change in dose or use of component? Assignment Algorithm – Additional Factors … 1 6
  17. 17. Solving FDA Legal Challenges for the Life of a Life Sciences Company -17- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Voluntary Formal Process under 21 CFR Part 3 ➢ Seeks to determine: – Regulatory Identity or Classification – Assignment of Lead Center – Collateral issue -- clarification of regulatory pathway ➢ If don’t seek RFD and submit for marketing, FDA may stay review clock while making designation determination ➢ Note – also can be used to get classification of a single component product, where you are not sure if drug, device, biologic … Not Sure of PMOA -- Requests for Designations (RFD's) 1 7
  18. 18. Solving FDA Legal Challenges for the Life of a Life Sciences Company -18- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ When to file RFD: – Before filing any application for investigational or marketing authorization – As soon as enough info exists for FDA to make a decision ➢ Can meet with OCP before filing RFD -- not required ➢ Regulation – 21 CFR 3.7 ➢ Guidance on How to Write a RFD – Federal Register – Monday, April 18, 2011 – 76 Fed. Reg. 21752 – http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM 251544.pdf ➢ Format – follow descriptions in 21 CFR 3.7(c)(1)-(3) ➢ Electronic filing – allowed, but not required ➢ 15-page limit (with attachments) RFD’s … 1 8
  19. 19. Solving FDA Legal Challenges for the Life of a Life Sciences Company -19- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT RFD Contents – 13 Sections • Contact Information • Product Name • Description of Product • Prior Approvals and Agreements • Chemical, Physical or Biological Composition • Development Work & Testing • Manufacturing Information • Proposed use or Indications • Modes of Action (all) and Primary Mode of Action • Schedule and Duration of Use • Dose and Route of Administration • Related Products • Other Relevant Information • Sponsor’s Recommendation on PMOA/classification and Center with jurisdiction 19
  20. 20. Solving FDA Legal Challenges for the Life of a Life Sciences Company -20- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Guidance – drills down on the 13 sections ➢ Some Key Points from the Guidance: – State how you think your product should be assigned and why • State the basis for your assertion why your selected PMOA is most important therapeutic action for the product • Assignment Algorithm -- if you cannot determine, “with reasonable certainty,” the PMOA, must use assignment algorithm (Slides 12 - 14) – Even if you are sure, should address anyway – Appropriate to file an RFD even if you believe that the product is NOT a combination product, but uncertainty remains RFD’s … 2 0
  21. 21. Solving FDA Legal Challenges for the Life of a Life Sciences Company -21- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ OCP reviews RFD’s for completeness w/in 5 work days ➢ If complete, OCP sends acknowledgement letter to sponsor, and copy of RFD’s to three Center liaisons ➢ Center recommendations due to OCP in 21 days ➢ Consultation among OCP, Centers and Office of Chief Counsel ➢ Decision reached, response letter prepared, necessary clearances obtained ➢ Decision must issue within 60 calendar days; if not YOUR recommendation wins!! RFD’s – OCP Process 2 1
  22. 22. Solving FDA Legal Challenges for the Life of a Life Sciences Company -22- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Request for Reconsideration – Submit within 15 calendar days – Cannot exceed 5 pages in your reconsideration submission – No new information (if you do, FDA will consider it a new RFD) – FDA response within 15 calendar days – FDA has been known to change a decision upon reconsideration ➢ Effect of RFD Letter – designated FDA Center can only be changed without your consent to protect the public health or another compelling reason. – Source: 21 CFR 3.9(b) RFD’s – Process … 2 2
  23. 23. Solving FDA Legal Challenges for the Life of a Life Sciences Company -23- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT The “Pre-RFD” Meeting/Request Feb. 2018 Guidance – “How to Prepare a Pre-Request for Designation (Pre-RFD)” • Highly recommended – – can submit at any time during product development – no limit on pages for submission – not binding (good if you don’t like the feedback) – does include inter-Center consultation – then can follow with formal RFD • FDA – written preliminary classification or jurisdictional assessment -- 60 calendar days 23 RFDvs.Pre-RFD • Can also request in-person meeting (could be via phone), but timing factors will vary
  24. 24. Solving FDA Legal Challenges for the Life of a Life Sciences Company -24- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ September 2017 -- Classification of Products as Drugs and Devices and Additional Product Classification Issues -- https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM258957.pdf – helpful guidance to appreciate differences between when a product has a drug vs. device vs. biologic MOA – reminds you that, particularly relative to devices, to be a medical device the “primary intended purpose” must not be chemical or metabolic activity. • THUS, if a product does generate some chemical activity, but (a) that chemical activity does not constitute the “primary intended purpose” and (b) the product otherwise meets the definition of a device, it IS a device even though it has some chemical activity. • See also, Section 503(g)(1)(E), discussed at Slide 13 Other Jurisdictional/Classification Actions
  25. 25. Solving FDA Legal Challenges for the Life of a Life Sciences Company -25- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ May 15, 2018 -- https://www.gpo.gov/fdsys/pkg/FR-2018-05-15/pdf/2018-10321.pdf – FDA characterizes as basically cleaning up various issues in 21 CFR Part 3 to address various changes that have occurred in past 15 years or so due to FDASIA and the Cures Act – Will substitute a total new version of Part 3 ➢ Stay tuned … has gotten some adverse comments Proposed Jurisdictional Rule 25
  26. 26. Solving FDA Legal Challenges for the Life of a Life Sciences Company -26- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Breath Test Combinations – http://www.fda.gov/CombinationProducts/JurisdictionalInformation/JurisdictionalUpdates/ucm103134.htm ➢ Heparin Catheter Lock-Flush Solutions – http://www.fda.gov/CombinationProducts/JurisdictionalInformation/JurisdictionalUpdates/ucm103161.htm ➢ Metered Dose Inhalers, Spacers and Other Accessories – http://www.fda.gov/CombinationProducts/JurisdictionalInformation/JurisdictionalUpdates/ucm10 3179.htm Jurisdictional Decisions -- Examples 2 6
  27. 27. Solving FDA Legal Challenges for the Life of a Life Sciences Company -27- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ January 22, 2013 – 78 Fed. Reg. 4307 • https://www.federalregister.gov/articles/2013/01/22/2013- 01068/current-good-manufacturing-practice-requirements-for- combination-products ➢ FDA: “The final rule is largely identical to the proposed rule.” 78 Fed. Reg. @ 4308. ➢ Creates 21 CFR Part 4 ➢ Effective date: 180 days after promulgation – July 22, 2013 ➢ Guidance Document – January 2017 – deep drill down Final Rules on GMPs 2 7
  28. 28. Solving FDA Legal Challenges for the Life of a Life Sciences Company -28- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Assumptions underlying final GMP rule: – During and after components combined, both sets of cGMP regulations apply (whether a single entity product or co-packaged products) – However, compliance with both sets of regulations can generally be achieved by using either regulation and agency does not see need for parallel systems ➢ Two options under final rule – Parallel systems -- satisfy all requirements for both systems – “Streamlined Approach” – full compliance with one system, plus compliance with designated parts of other system [where other system is not your usual system] IS full compliance with all of second system GMPs … 2 8
  29. 29. Solving FDA Legal Challenges for the Life of a Life Sciences Company -29- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Must meet all drug GMP rules, plus these device Quality System rules: – 820.20 – Management Responsibility – 820.30 – Design Controls – 820.50 – Purchasing Controls – 820.100 – Corrective and Preventive Action (CAPA) – 820.170 – Installation – 820.200 – Servicing • 21 CFR 4.4(b)(1) Streamlined – Drug "Dominant" 2 9
  30. 30. Solving FDA Legal Challenges for the Life of a Life Sciences Company -30- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Must meet all device Quality System rules, plus these drug GMP rules: – 211.84 – Testing and approval or rejection of components, drug product containers, and closures – 211.103 – Calculation of yield – 211.132 – Tamper-evident packaging for OTC drugs – 211.137 – Expiration dating – 211.165 – Testing and release for distribution – 211.166 – Stability testing – 211.167 – Special testing requirements – 211.170 – Reserve Samples • 21 CFR 4.4(b)(2) Streamlined – Device "Dominant" 3 0
  31. 31. Solving FDA Legal Challenges for the Life of a Life Sciences Company -31- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ June 13, 2018 – 83 Fed. Reg. 27609 ➢ Includes a list of acceptable alternative approaches for certain aspects of streamlined GMP compliance – very technical drill down; will not review in detail here ➢ Drug issues addressed: – 211.165 – Testing & Release for Distribution – 211.166 – Stability Testing – 211.167 – Special Testing Requirements – 211.170 – Reserve Samples ➢ Device issues addressed – 820.30 – Design Controls – GMP exempt devices – are exempt for the device component of a combination product ➢ Discusses how to interact with FDA if you have GMP concerns on combination products. Notice on Alternative GMP Approaches 31
  32. 32. Solving FDA Legal Challenges for the Life of a Life Sciences Company -32- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ What governs in investigational stage? – Phase 1 – drug component exempt from drug GMPs – Device component – exempt, except design controls in all phases ➢ Does it apply to already approved combination products? – Yes; the rule does not change what applies, but creates a system for understanding how to apply the distinct GMP rules ➢ Defined “convenience kits” – “ … only kits that solely include products that are: (1) Also legally marketed independently and (2) included in the kit as already packaged and with the same labeling as for independent marketing. GMPs – Issues Addressed in Final Rule 3 2
  33. 33. Solving FDA Legal Challenges for the Life of a Life Sciences Company -33- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ What if two provisions (QSR v. Drug GMP) appear to clash? – follow the one more “specifically applicable to the constituent part” (if you can figure that out) – 78 Fed. Reg. at 4314 ➢ What happens while a constituent part is being made at a separate facility? – all CGMP provisions applicable to that constituent part (i.e., drug, device, or biologic) must be satisfied at that facility • and … when it is brought to another facility where it is combined with a different constituent part, then you have to meet the CGMPs that apply to both … • but … you can use the “streamlined” approach GMPs – Issues Addressed in Final Rule 3 3
  34. 34. Solving FDA Legal Challenges for the Life of a Life Sciences Company -34- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Design controls – – to be addressed in guidance – “The design history file for a combination product … must address all design issues resulting from the combination of the constituent parts, regardless of whether” the manufacturer picks a “drug dominant” or “device dominant” scheme (or full implementation of both) – 78 Fed. Reg. 4315 – Examples: • document and provide objective evidence that the drug is appropriate for use with the device – e.g., why a particular drug will work with a drug- eluting stent • document that the device is appropriate for the drug -- e.g., that a syringe will not interact with the drug GMPs – Issues Addressed in Final Rule 3 4
  35. 35. Solving FDA Legal Challenges for the Life of a Life Sciences Company -35- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Blood and blood component products – also must meet requirements of 21 CFR Part 606 ➢ Human Cellular and Tissue-based Products (HCT/Ps) – Current Good Tissue Practices apply if product is also regulated as a drug, device or biologic – Section 361 of Public Health Service Act – if HCT/P is combined with another article (other than water and certain other agents), it is a drug, device or biologic – 21 CFR 1271 will apply if the HCT/P is also part of a combination product, especially the Good Tissue Practice rules at 21 CFR 1271.145 et seq. GMPs -- Special Cases 3 5
  36. 36. Solving FDA Legal Challenges for the Life of a Life Sciences Company -36- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Final Rule -- Federal Register, Dec. 20, 2016 – https://www.gpo.gov/fdsys/pkg/FR-2016-12-20/pdf/2016- 30485.pdf ➢ Basic approach – Generally will follow the reporting system applicable to the type of marketing application under which cleared (if single application) -- NDA/PMA or 510(k)/BLA – Assumption – the systems are “substantially similar” – But, there are seven types of safety reports that are unique – have to see if one applies, in your scenario, to your combination product Post-Marketing Safety Reporting 3 6
  37. 37. Solving FDA Legal Challenges for the Life of a Life Sciences Company -37- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ 5-Day Report – under Medical Device Reporting (MDR) Rule – when you learn of a reportable event associated with the device that necessitates remedial action to “prevent an unreasonable risk of substantial harm” to public health ➢ 30-Day Device Malfunction Report – under MDR, get info that “reasonably suggests” the device has malfunctioned and, if malfunction were to recur, the device or a similar device you market would be likely to cause or contribute to death or serious injury ➢ Part 806 – Reports of Corrections – have 10 working days from initiating a correction or removal subject to Part 806 (i.e., a Class I or II recalls; Class III recalls are not subject to 806) The Seven Unique Safety Reports 3 7
  38. 38. Solving FDA Legal Challenges for the Life of a Life Sciences Company -38- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ 15-Day Alert – for drugs and biologics – reports of a serious and unexpected adverse event – Note: under MDR, “serious” events are reportable in 30 days, but MDR does not talk about unexpected, so 15-day Alert governs where a combination product containing a device has a serious and unexpected event if you can’t determine which component caused the AE ➢ 3-Day Field Alert – for drugs only under 21 CFR 314.81(b)(1) – certain types of problems with drugs such as: bacteriological contamination, failure to meet specifications (e.g., stability) or labeling errors that could lead to product mix-ups ➢ Expedited Blood Fatality Report – if blood collection or transfusion is fatal, has to be reported in 7 days of the fatality ➢ Biological Product Deviation Reports – 21 CFR 606.171 – 45 days from when you discover a GMP or other deviations that can affect safety, purity, or potency The Magnificent Seven … 3 8
  39. 39. Solving FDA Legal Challenges for the Life of a Life Sciences Company -39- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ If a single application covers the combination: – Use reporting rules required under the particular application – As applicable under factual scenario, use one of Seven Types ➢ When two applications cover the combination: – If you can reasonably conclude which component caused the adverse event, you can use that component’s reporting system – If unclear which component caused AE, have to satisfy reporting requirement of all types of application – If other application is held by a third party, have to notify that person within 5 days of learning of event and also satisfy your reporting duties The Safety Rule in Action 3 9
  40. 40. Solving FDA Legal Challenges for the Life of a Life Sciences Company -40- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Compliance Policy – “immediately in effect” – FDA delays effective dates of five provisions of 12/16 Final Rule to allow applicants to update systems and procedures – Affected • 4.102(c) – combination applicants where product has a drug component • 4.102(d) – “other reporting requirements” • 4.104(b)(1) – where to submit a drug report • 4.104(b)(2) – where to submit a device report • 4.105(b) – record retention lengths – Delayed effective dates: • July 31, 2019 – if you use FAERS or eMDR • January 31, 2020 – if you use VAERS March 2018 PSMR/AE Guidances 40
  41. 41. Solving FDA Legal Challenges for the Life of a Life Sciences Company -41- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Draft Guidance – “Postmarketing Safety Reporting for Combination Products” ➢ This draft guidance is a deep drill down of the Final Rule – won’t discuss here as not in effect yet March 2018 PSMR/AE Guidances … 41
  42. 42. Solving FDA Legal Challenges for the Life of a Life Sciences Company -42- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Concept Paper on Marketing Applications for Combination Products – http://www.fda.gov/downloads/CombinationProducts/RequestsforComment/UCM108197.pdf ➢ Basics: – PMOA does not ensure application status; but lead Center – Single application usually is sufficient and, per Cures Act, FDA is to use a single app. “whenever appropriate” – 503(g)(1)(B) – Exceptions • One component is already approved, but labeling will need to be changed • Biologics – legally can have separate apps. for components • When the components are “separate and complex” – e.g., a device in combination with a new molecular entity drug/biologic • Where needed to “apply mechanisms to ensure appropriate regulation or unique regulatory requirements” not available under one app. – Example: gene therapy How Many Applications? 4 2
  43. 43. Solving FDA Legal Challenges for the Life of a Life Sciences Company -43- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ You Might Want Two – perhaps: – To qualify for Waxman-Hatch Exclusivity – Orphan Drug Status – To protect proprietary data if 2 firms are involved ➢ Complex decision tree suggested in concept paper on how these are handled How Many Applications?... 4 3
  44. 44. Solving FDA Legal Challenges for the Life of a Life Sciences Company -44- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Guidance on User Fees for Combination Products – April 2005 – http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM147118.pdf ➢ Basics – Depends on type and # of applications – If two applications submitted voluntarily, pay two fees – If two applications REQUIRED, still pay two fees ➢ “Innovative Product Waiver” – consider seeking User Fees – Can I Pay the Least Amount? 4 4
  45. 45. Solving FDA Legal Challenges for the Life of a Life Sciences Company -45- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Combination Products Main Homepage – http://www.fda.gov/CombinationProducts/default.htm ➢ Frequently Asked Questions on Combination Products – http://www.fda.gov/CombinationProducts/AboutCombinationProducts/ucm101496.htm ➢ Jurisdictional Determinations – – http://www.fda.gov/CombinationProducts/JurisdictionalInformation/RFDJurisdictionalDecisions/default.htm ➢ Final Rule on “Primary Mode of Action” – 8/25/2005; 70 Fed. Reg. 49848 – https://www.gpo.gov/fdsys/pkg/FR-2005-08-25/pdf/05-16527.pdf ➢ SMG 4011 – Inter-Center Consultative/Collaborative Review Process – http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/StaffManualGuides/UCM283569.pdf References 4 5
  46. 46. Solving FDA Legal Challenges for the Life of a Life Sciences Company -46- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT Category Title Type Date Post-market Postmarketing Safety Reporting for Combination Products Draft 3/2018 Post-market Compliance Policy for Combination Product Postmarketing Safety Reporting Final 3/2018 Jurisdictional How to Prepare a Pre-Request for Designation (Pre-RFD) Final 02/2018 Jurisdictional Classification of Products as Drugs and Devices and Additional Product Classification Issues Final 09/2017 Post-market Current Good Manufacturing Practice Requirements for Combination Products(PDF - 336KB) Final 01/2017 Pre-market Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development(PDF - 336KB) Draft 02/2016 Pre-market Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products (PDF - 153KB) Final 06/2013 Pre-market Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4 Draft 04/2013 Post-market Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA (PDF - 101KB) Draft 01/2013 Jurisdictional Interpretation of the Term "Chemical Action" in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act Draft 06/2011 Jurisdictional How to Write a Request for Designation (RFD) Final 04/2011 Pre-market New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products (PDF - 159KB) Final 12/2009 Jurisdictional Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Final 07/2007 Pre-market Early Development Considerations for Innovative Combination Products Final 09/2006 Pre-market Application User Fees for Combination Products Final 04/2005 Pre-market Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product Final 05/2004 FDA List of Combination Prod. Guidances 46
  47. 47. Solving FDA Legal Challenges for the Life of a Life Sciences Company -47- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT 47 OVER-THE-COUNTER -- “OTC” -- DRUGS
  48. 48. Solving FDA Legal Challenges for the Life of a Life Sciences Company -48- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ OTC Review – monograph system – By regulation, FDA makes a “GRASE” determination – thus, not a “new drug” – Covers bulk of marketed OTCs – Lacks exclusivity ➢ Rx – OTC Switches – May enjoy patent protection – May enjoy Waxman-Hatch Exclusivity • Yes – most • No -- Minoxidil ➢ Direct-to-OTC – Very, very rare – Only ones I know are both local – • Avanir’s Abreva®; • SalonPas® -- Hisamatsu OTC’s – Three Routes
  49. 49. Solving FDA Legal Challenges for the Life of a Life Sciences Company -49- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT Why Switch? ➢ Preserve franchise in face of impending generic competition on the Rx ➢ Boost sales ➢ Downside – Usually not reimbursed by insurance
  50. 50. Solving FDA Legal Challenges for the Life of a Life Sciences Company -50- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT OTC’s – Key Issues ➢ Wellpoint Petition – sought to “force” Claritin OTC ➢ Will FDA file its own petitions? ➢ T.E.A. Rule – foreign data can now be used to support an OTC Switch ➢ What studies are sufficient to support Waxman-Hatch Exclusivity? – Make sure they’re essential – Minoxidil – More than one similar product can get exclusivity
  51. 51. Solving FDA Legal Challenges for the Life of a Life Sciences Company -51- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Tamper-resistant packaging – required by 21 CFR 211.132 – for OTC drugs (except topicals, dentrifices, insulin, and throat lozenges) ➢ Can’t be an Rx and an OTC (per FDA) – but, see Miralax generics challenge ➢ Adverse events – PL 109-462, the Dietary Supplement and Nonprescription Drug Consumer Protection Act, December 2006 – Serious adverse events must be reported by person listed on label – Draft guidance – 2007 – for those OTCs not under an A/NDA Other OTC Drug Requirements 51
  52. 52. Solving FDA Legal Challenges for the Life of a Life Sciences Company -52- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT OTC Drug Labeling 52 • Standardizedto“DrugFacts”–21CFR201.166
  53. 53. Solving FDA Legal Challenges for the Life of a Life Sciences Company -53- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT Reforming the System • Legislation – Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 – HR 5333 -- (passed House on July 16) – S. 2315 – approved by committee • FDA views – Woodcock testimony before Congress – Sept. 2017 – Gottlieb statement – July 2018 – Draft guidance -- Innovative Approaches for Nonprescription Drug Products
  54. 54. Solving FDA Legal Challenges for the Life of a Life Sciences Company -54- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT Orphan Drugs
  55. 55. Solving FDA Legal Challenges for the Life of a Life Sciences Company -55- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Enacted – 1983 ➢ Goal -- create incentives for pharmaceutical companies to adopt "orphan" drugs for uses for rare disorders. ➢ “Orphan" -- many drugs were known as potentially effective for rare diseases, but had been orphaned -- abandoned for developmental purposes -- by the pharmaceutical industry due lack of profitability associated with small patient population (aka “buyers”) ADOPTING ORPHANS – The Orphan Drug Act
  56. 56. Solving FDA Legal Challenges for the Life of a Life Sciences Company -56- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Orphan Drug Act -- created four key incentives to facilitate drug development for rare diseases: – Seven years marketing exclusivity during which time no other company can secure approval for the same drug for the orphan indication – Protocol assistance – Tax credits – Research Grants Orphans . . .
  57. 57. Solving FDA Legal Challenges for the Life of a Life Sciences Company -57- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ To qualify for benefits under the Orphan Drug Act, a drug must serve a patient population: – < 200,000 people in the United States or – if > 200,000, orphan drug applicant must show it cannot reasonably recoup its commercial investment in the research and development of the product – • rarely used ➢ Key question for orphan drug status is patient population -- – the indication sought must be “medically plausible” – not just a "salami sliced" indication of a greater patient population that might be otherwise over 200,000. How Does a Drug Become an Adoptable Orphan?
  58. 58. Solving FDA Legal Challenges for the Life of a Life Sciences Company -58- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ To get orphan drug benefits, a sponsor must apply for orphan drug designation. ➢ Process -- sponsor-specific ➢ 21 CFR 316.20 requires that, among other things, the sponsor show: – patient population proposed -- less than 200,000 people per year. – is a confidential process with the designation application not being one subject to public disclosure until after it is approved, if it is approved. ➢ Once approved, the designation will appear in a quarterly cumulative list that the Agency publishes and makes available on its website. ➢ Several guidances available Orphan Designation
  59. 59. Solving FDA Legal Challenges for the Life of a Life Sciences Company -59- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT Designation Issues – or Can Identical Drugs Be Adopted by Two Different Families – or does one Drug have to be Superior? ➢ Clinical Superiority – FDA may regard – for Orphan Drug Act purposes, including exclusivity -- as different, drugs that are chemically the same and for same indication if the second drug is clinically superior to the first drug – prior to 2017’s Food & Drug Administration Reauthorization Act (FDARA), FDA had construed the ODA that you had to show superiority – BUT, a 2014 court case – Depomed (re Gralise®) had found that superiority was not required – in effect, you could have two drugs with O.D. exclusivity • FDA – after Depomed, said it would ignore the court’s decision – FDARA resolved this for drugs subject to the ODA after the enactment date of FDARA (August 18, 2017)
  60. 60. Solving FDA Legal Challenges for the Life of a Life Sciences Company -60- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ 3 Types of Clinical Superiority – each must show that it presents a “significant therapeutic advantage” as to either: – Greater Efficacy; or – Greater Safety; or – Providing a Major Contribution to Patient Care (“MC-PC”) ➢ How to Prove Superiority – 21 CFR 316 – Effectiveness – “as assessed by effect on a clinically meaningful endpoint in adequate and well controlled trials” • typically – direct, head-to-head, clinical trials (as per a comparative claim) – Safety – “in a substantial portion of the target population” Clinical Superiority 60
  61. 61. Solving FDA Legal Challenges for the Life of a Life Sciences Company -61- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Very subjective; some factors FDA will consider (from 2013 revised regulations); – Convenient treatment location (e.g., home vs. clinic) – Reduced treatment burden – Increased patient comfort – Improved administration – Potential for self-administration ➢ Not MC-PC: – Increased quality of life – Improved patient compliance How to Prove MC-PC Superiority
  62. 62. Solving FDA Legal Challenges for the Life of a Life Sciences Company -62- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Efficacy – Serono’s Rebif >to Avonex for relapsing-remitting MS based on a head-to-head clinical study (2002) ➢ Safety – Biogen’s Avonex > Berlex’s Betaseron due to a reduced risk of an adverse event – injection site necrosis ➢ MC-PC – Academic’s Sotalol HCl > Betapace due to change in dosage form from oral to injectable allowed use with patients that could not use oral dosage – Eagle’s Ryanodex > Dantrium IV because anesthesiologist could prepare in 1 minute vs. 1 hour for Dantrium, allowing anesthesiologist to concentrate on treating the patient Clinical Superiority (“>”) – Examples 62
  63. 63. Solving FDA Legal Challenges for the Life of a Life Sciences Company -63- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ FDA Final Rule – July 2013 – situations where a viable orphan subset may exist in a “non-rare” disease – Toxicity of the drug – e.g., a small subset are refractory to normal treatment, but would respond to a more toxic drug – Mechanism of action – e.g., breast cancer is not rare, but those where the drug mechanism impacts a specific biomarker where the population is orphan ➢ Illegitimate slicing – Disease grade – e.g., all breast cancer stages are seen as same disease; but contrast – FDA says pneumonia in CF patients is different disease than community-acquired pneumonia – Clinical trial – inclusion/exclusion criteria – can’t pick only “left- handed lawyers” Subsets – Legitimate “Salami Slicing”
  64. 64. Solving FDA Legal Challenges for the Life of a Life Sciences Company -64- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ “Molecular differentiation” (my term) -- in other cases, FDA has gone to some length to differentiate a product on the basis of how its molecular structure differs from an approved orphan drug. – “Silly Little Amino Acid” Case – 91 vs. 92 amino acid chains “Same” Drug? 64
  65. 65. Solving FDA Legal Challenges for the Life of a Life Sciences Company -65- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT Orphan Drug Exclusivity ➢ Protects the orphan drug for the orphan indication ➢ 7 years ➢ Good thing – can’t “remake wheel” (distinguish Waxman-Hatch exclusivity which does not bar a full NDA for a drug with W-H exclusivity) ➢ Beware – less incentive to study approved drugs for orphan uses – generics may come in and be used off- label
  66. 66. Solving FDA Legal Challenges for the Life of a Life Sciences Company -66- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Only helpful to a company that is actually enjoying taxable income that needs to be offset. ➢ For startups, this may not occur any time in the short term when the needs of the tax cut might be most useful. ➢ See a tax professional -- may be able to give you more advice as to whether any losses can be carried forward and for how long so as to be able to take advantage of the tax cut provisions ➢ Most observers -- low utility Tax Credits
  67. 67. Solving FDA Legal Challenges for the Life of a Life Sciences Company -67- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT Protocol Assistance ➢ Orphan Drug sponsors are as eligible for significant additional assistance from FDA in the design of its clinical study protocols (caveat: nature of that aid is not stated very clearly anywhere) ➢ LINK any assistance to a clear written agreement with the Agency as to the nature of the clinical studies to be performed
  68. 68. Solving FDA Legal Challenges for the Life of a Life Sciences Company -68- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT Research Grants ➢ Awarded by FDA to qualified applicants pursuant to criteria being articulated by the Agency. ➢ While the grants can be somewhat substantial, they are dependent upon the Agency receiving appropriate funding by Congress for the grants. ➢ Fairly constant struggle for FDA -- historically the gross amount of grants available in a single year rarely exceeds $2 million and individual grants normally range from $50,000 to $200,000. ➢ Qualifying for a grant involves a number of hurdles
  69. 69. Solving FDA Legal Challenges for the Life of a Life Sciences Company -69- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Commissioner Blog -- June 29, 2017 – Announced -- Goals & Features – Eliminate backlog within 90 days – 100% of new O.D. Designation requests to get response in 90 days – Webinar Tutorial on Designation Requests • access at: https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanP roductDesignation/ucm597126.htm – Plan – access at: • https://www.fda.gov/downloads/ForIndustry/DevelopingProductsforRareDiseasesConditions/Howtoapply forOrphanProductDesignation/UCM565068.pdf ➢ Draft Guidance – Dec. 2017 -- Designation for Pediatric Subpopulations of Common Diseases FDA O.D. Modernization Plan 69
  70. 70. Solving FDA Legal Challenges for the Life of a Life Sciences Company -70- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ O.D. Designation Pilot Plan – fillable designation form ➢ Public workshop – held on May 9, 2018 -- to address changing landscape of O.D. development posed by targeted therapies and molecularly defined diseases. – https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm592778.htm ➢ MOU with NORD -- for collaboration to enhance patient involvement in regulatory discussions ➢ More at: https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/Events/u cm593077.htm FDA – 2018 Rare Disease Day Announcements 70
  71. 71. Solving FDA Legal Challenges for the Life of a Life Sciences Company -71- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ No difference in standards for approval – still must prove “substantial evidence” of safety and effectiveness using adequate and well-controlled investigations and clinical benefit ➢ Clinical study hurdles – Small patient populations • Hard to recruit • Clinical investigators – more likely to be “naïve” as to Good Clinical Practices (GCP) – Poorly understood disease processes – Many orphan diseases are genetically based – estimated as high as 80% -- thus, can be very heterogeneous populations – confounding study predictability Challenges in Orphan Drug Development 7 1
  72. 72. Solving FDA Legal Challenges for the Life of a Life Sciences Company -72- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Clinical study hurdles … – Often chronic, progressive, serious, life-limiting and life- threatening with unmet medical needs – Endpoints, outcome measures, tools, instruments, biomarkers usually lacking – “Natural history” of diseases simply not as well documented ➢ Clinical study differences – examples: – Carglumic acid – for NAGS deficiency – approved with just one study – an open label, historically controlled, retrospective cases series of 23 subjects – Dalfampiridine – to improve walking in patients with multiple sclerosis – two randomized, placebo controlled studies with 540 subjects Orphan Drug Development Challenges … 7 2
  73. 73. Solving FDA Legal Challenges for the Life of a Life Sciences Company -73- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT ➢ Tougher to recruit for many reasons – Less of them – Ethical considerations • Informed consent/assent • Willingness of parent or guardian – Organ development differences – not just proportionally smaller adults – High genetic involvement Clinical Challenges – Rare Pediatric Diseases
  74. 74. Solving FDA Legal Challenges for the Life of a Life Sciences Company -74- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT Statistics – A Very Successful Law 74
  75. 75. Solving FDA Legal Challenges for the Life of a Life Sciences Company -75- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT 75 Source: “Insights into Rare Disease Drug Approval: Trends and Recent Developments.” Lanthier, Mike (Operations Research Analyst, FDA Office of Commissioner). NORD Rare Diseases & Orphan Products Breakthrough Summit. October 17, 2017. at Slide 4.
  76. 76. Solving FDA Legal Challenges for the Life of a Life Sciences Company -76- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT Source: Lanthier, at Slide 7.
  77. 77. Solving FDA Legal Challenges for the Life of a Life Sciences Company -77- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT Source: Lanthier, at Slide 11.
  78. 78. Solving FDA Legal Challenges for the Life of a Life Sciences Company -78- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT aaaa aaaa Source: Lanthier, at Slide 12.
  79. 79. Solving FDA Legal Challenges for the Life of a Life Sciences Company -79- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT 2017 O.D. Approvals – Therapeutic Areas
  80. 80. Solving FDA Legal Challenges for the Life of a Life Sciences Company -80- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT Source: Lanthier, at Slide 15.
  81. 81. Solving FDA Legal Challenges for the Life of a Life Sciences Company -81- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT Time to Market 81
  82. 82. Solving FDA Legal Challenges for the Life of a Life Sciences Company -82- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT 82 Source: https://csdd.tufts.edu/csddnews/
  83. 83. Solving FDA Legal Challenges for the Life of a Life Sciences Company -83- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT Questions? ➢ Call, e-mail or write: Michael A. Swit, Esq. LAW OFFICES OF MICHAEL A. SWIT San Diego, California 92130 m: 760-815-4762 e: mswit@fdacounsel.com web: www.fdacounsel.com ➢ Follow me on: – LinkedIn: http://www.linkedin.com/in/michaelswit – Twitter: https://twitter.com/FDACounsel
  84. 84. Solving FDA Legal Challenges for the Life of a Life Sciences Company -84- www.fdacounsel.com LAW OFFICES OF MICHAEL A. SWIT About Your Speaker Michael A. Swit, Esq., has been addressing critical FDA legal and regulatory issues for over 30 years. Before returning to his private law practice in late 2017, he served for 3 years as the chief regulatory counsel at a leading developer of diagnostics and research tools. Prior to that, Swit was a special counsel in the FDA Law Practice at the global law firm of Duane Morris LLP, in its San Diego office. Before joining Duane Morris in March 2012, Swit served for seven years as a vice president at The Weinberg Group Inc., a preeminent scientific and regulatory consulting firm in the Life Sciences. His expertise includes product development, compliance and enforcement, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts for all types of life sciences companies, with a particular emphasis on drugs, biologics, therapeutic biotech products, medical devices, and IVDs. His FDA legal and regulatory work also has included tenures in private practice with McKenna & Cuneo and Heller Ehrman, and as vice president, general counsel and secretary of Par Pharmaceutical, a top public generic and specialty drug firm, where he helped spearhead the company’s emergence from the Generic Drug Scandal. He also was, from 1994 to 1998, CEO of FDANews.com, a premier publisher of regulatory newsletters and other specialty information products for FDA-regulated firms. He has taught and written on many topics relating to FDA regulation and associated commercial activities and is a past member of the Food & Drug Law Journal Editorial Board. He earned his A.B., magna cum laude, with high honors in history, at Bowdoin College, and his law degree at Emory University.

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