Presentation

1. How to Establish and Maintain a GoodHow to Establish and Maintain a Good
Working Relationship with allWorking Relationship with all
Regulatory AgenciesRegulatory Agencies
Jerome J. Gainer, ASQ Certified GMP
Pharmaceutical Professional and
ASQ Certified Quality Engineer
Originally Presented at
Pet Industry Advisory National Forum Series
By

2. Which of these quotes shouldWhich of these quotes should
describe your attitude concerningdescribe your attitude concerning
Regulators and Regulations?Regulators and Regulations?
“A civil servant [in a regulatory agency] is like a broken
cannon. It won’t work and you can’t fire it.”
—George S. Patton
OR
“It is bad policy to regulate everything where things may
better regulate themselves and can be promoted by private
exertion, but it is no less bad policy to let those things
alone which can only be promoted by interfering social
power.”
—Friedrich List

3. What is the ultimate authorityWhat is the ultimate authority
for Animal Healthfor Animal Health
Regulations?Regulations?
“Let us make man in our image, in our likeness,
and let them rule over the fish of the sea, and the
birds of the air, over livestock over all the earth,
and over all the creatures that move along the
ground.”
–God

4. Is It Important to Have GoodIs It Important to Have Good
Relationships with these Agencies?Relationships with these Agencies?
 Striving for a great relationship with all regulators should
be viewed as a top priority.
 Good relationships with all regulatory agencies will avoid
the following:
 Interruption in profitable activities to satisfy an
agency
 Delays in approval of new products
 Failure to achieve approval of new products
 Market withdrawals for registration issues
 Recalls, lost of reputation for quality
 Loss of market share, devaluation of stock price
 Failure to meet company goals, loss of bonus
opportunity

5. How Do You Know When YourHow Do You Know When Your
Company Has Achieved GreatCompany Has Achieved Great
Regulator Relationships?Regulator Relationships?
 Goals and progress toward goals requiring regulatory
agency assistance or approval are being met.
 Your requests to agencies (such as more time to respond)
are being granted.
 Without prompting, agency offers to assist you.
 Company is fully compliant with regulatory requirements.

6. Regulatory Agencies We Deal with inRegulatory Agencies We Deal with in
Animal HealthAnimal Health
 Center for Veterinary Medicine (part of FDA)
 US Federal Trade Commission
 US EPA (Environmental Protection Agency)
 USPTO (Patent and Trademark Office)
 DEA (Drug Enforcement Agency)
 VDD (Canadian equivalent of CVM)
 MHRA (English equivalent of FDA)
 Your state food and drug agency

7. Regulatory Agencies in AnimalRegulatory Agencies in Animal
HealthHealth
 Your state board of pharmacy
 Local city environmental agencies
 Office quebecois de la langue francaise (Quebec language
police)
 Various industry groups such as AAFCO and National
Animal Supplement Council

8. What Specifics Do I Need to KnowWhat Specifics Do I Need to Know
about Each Agency?about Each Agency?
 What are this agency’s “hot button” issues?
 What power/affect can they have on my business?
 What reoccurring submissions/documents must be
prepared?
 What routine/extraordinary cost can I expect?
 What level of trust have I built with this agency?
 How can I get a yes to my request/submission?
 How can I stay off of their problems list?

9. Hot Button IssuesHot Button Issues
 Center for Veterinary Medicine
 Recalls
 Illegal advertising and promotion
 Misbranded labels
 Unprofessional new drug applications

10. Hot Button IssuesHot Button Issues
 Center for Veterinary Medicine
 Quality system failures in GMP inspections (483’s)
 Failure to submit post approval documents (MCSR)
 Disrespect of agency employees
 Outright fraud

11. Hot Button IssuesHot Button Issues
 Environmental Protection Agency
 Failure to submit Quarterly Pharmacovilgilence
 EPA report on quantity of pesticide manufactured
 Changes to EPA approved labels
 Failure to respond to Data Call-in Request

12. Hot Button IssuesHot Button Issues
 Environmental Protection Agency
 Failure to follow up on PR notices
 Failure to register a plant that makes any part of a
FIFRA product
 Performing EPA testing in non GLP facility
 Making changes to Confidential Statement of
Formula

13. Hot Button IssuesHot Button Issues
 Veterinary Drug Directorate (Canada CVM)
 Not maintaining GMP compliance of US
manufacturing site (Not able to register facility)
 Unacceptable French Language translation
 Failure to establish a QA release operations on
Canadian soil (for DIN products)
 Importance of documents (as VDD audit will be be
conducted in Canada even if plant is in USA)
 Preparing a thorough Site Master File
 Import issues

14. Hot Button IssuesHot Button Issues
 MHRA (English equivalent of FDA)
 Poor outcome of on site inspection concerning:
– Facilities
– Changes
– Quality Issues (critical deficiencies)
 Poorly prepared site master file
 Inaccurate/late compliance report (questionnaire)
 Batch to batch variations
 Failure to submit updates
 Failure to follow up on previous deficiencies

15. Hot Button IssuesHot Button Issues
 State Boards of Pharmacy
 License required for manufacturer/distributor of
prescription animal drugs
 Inspection of the manufacturing/distribution site for
– General Sanitation
– Temperature history in storage area vs label
– Expiration date of drugs
– DEA security
– Invoice matching
– Overall security of site and drugs from
pilfering/theft

16. Things to Do to Establish/MaintainThings to Do to Establish/Maintain
Great Regulator RelationshipsGreat Regulator Relationships
 Demonstrate competence in verbal and written
communications.
 Provide supporting documentation for any claims.
 Strive to be clear, scientifically justifiable, logical, and
well organized in written communication.
 Take advantage of meeting regulators at stakeholder
meetings and other venues.

17. Things to Do to Establish/MaintainThings to Do to Establish/Maintain
Great Regulator RelationshipsGreat Regulator Relationships
 Demonstrate familiarity with challenges that your
regulator may have when speaking with them.
 Respect and utilize the expertise of your regulator when
needed.
 Be honest in all your documentation, and do not try to hide
obvious problems. Instead show them how you propose to/
or have corrected the problem.
 Express appreciation and respect to regulators for help
they give.

18. Things to Do to Establish/MaintainThings to Do to Establish/Maintain
Great Regulator RelationshipsGreat Regulator Relationships
 Be holistic in correcting a problem. Do not just correct the
one instance that the regulator pointed out to you.
 Become familiar with guidance documents.
 Clarify the regulators question before you try to answer it.
 Give full, complete and truthful responses to the exact
question that is asked.
 Keep an accurate and complete record of communications
with regulators.

19. Things to Do to Maintain GreatThings to Do to Maintain Great
Regulator RelationshipsRegulator Relationships
 Pick your battles carefully.
 Do recognize that although guidance and statues may
appear to be written in stone, good science and logic can
prevail.
 Maintain a good record with regulators.
– Respond by due dates or request more time.
– Provide quality professional work.
 Strive for win/win solutions.
 Clear up misunderstandings and summarize discussions.

20. Things Not to Do to Maintain GreatThings Not to Do to Maintain Great
Regulator RelationshipsRegulator Relationships
 Don’t refer to regulators as just “bureaucrats” or provoke
them with hostile comments.
 Don’t provoke regulators in written communications by
offensives words, unnecessary bolding or capitalization.
 Don’t disrespect agency employees regardless of race,
gender, or religion.
 Don’t be afraid to ask for what you want—but try to
supply them with logical, scientifically based reasons why
they should agree.

21. How to Establish and Maintain aHow to Establish and Maintain a
Great Working Relationship with AllGreat Working Relationship with All
Regulatory AgenciesRegulatory Agencies
Questions?
Questions?
Questions?