3 Things Your Lawyer Wants You To Know Kam
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Compliance for sales representatives. What you need to be aware of.
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- 1. 3 T IPS Y OU N EED To K NOW : B UT M AY S CARE Y OU D ARSHAN K ULKARNI P HARM.D , M S , E SQ @F DALAWYERS T HE K ULKARNI L AW F IRM
- 3. Bad News
- 7. A N O UNCE O F P REVENTION I S B ETTER T HAN A P OUND O F C URE
- 9. What’s Next?
Editor's Notes
- Funded by Orphan Medical, which was bought by Jazz Pharmaceuticals. promoted drug (Xyrem) for day time sleepiness, off-label when promoted, but was approved for later. Company : Jazz Pharma took a plea bargain. Alfred Coronia : Sales Rep Jury, convicted the sales rep on the charge of conspiracy to misbrand Xyrem. Received one year probation, 100 hours community service, and a $25 fine. Dr. Peter Gleason Arrested in 2006 for off-label promotion of Xyrem. Dr. Gleason pled guilty to one misdemeanor with no intent, sentenced to one year of probation and paid a $25 fine. Brought in by Coronia. Informant Doc “pumped him” for off-label questions. Which he answered. Dr. Gleason died. Nevertheless, the Florida Department of Health filed an administrative complaint against him earlier this year.
- Facts: Purdue Fredrick Recommended dosing Oxycontin q8h instead of q12h. Resulted in more AEs. Resulted in false claims being submitted to HHS. Company admitted: “Some employees made, or told other employees to make, certain statements about OxyContin to some healthcare professionals that were inconsistent with the FDA-approved prescribing information for OxyContin and the express warnings it contained about risks associated with the medicine," Result : Company : pled guilty to felony misbranding of OxyContin with the intent to defraud and mislead. $276 million will be forfeited to the United States, $160 million allocated to federal and state government agencies to resolve false claims for government healthcare programs and $130 million will go to resolving private civil claims. Plus a $19.5 million settlement the related manufacturer of OxyContin, Purdue Pharma, made with 26 states and the District of Columbia over allegations it failed to adequately disclose abuse risks posed by the powerful narcotic. Purdue Pharma had also settled a civil case brought by its insurer in June for $200 million. Individual : Its president, chief legal officer and former chief medical officer pleaded guilty to a misdemeanor charge of misbranding three years’ probation, 400 hours of community service, and a $5,000 fine. Mr. Friedman paid $19 million, Mr. Udell $8 million, and Dr. Goldenheim $7.5 million, all of which went to Virginia’s Medicaid Fraud Control Unit. 20 year period reduced to 15-year exclusion converted to a 12 year exclusion from all Federal health care.
- “ Deputizes” HCPs Only been one year End of Jan, agency recd 239 complaints , a little over half of which were from HCPs. 31% of which were from consumers. Around 135 were deemed deserving of further investigation, though only half fell under DDMAC's jurisdiction Allows anonymous submissions Examples : 1. Issued in December to Hill Dermaceuticals for part of its website for Derma-Smoothe Body Oil, a dermatitis treatment. Hill Dermaceuticals president Jerry Roth Advertising Age he believes the complaint came from a rival company. 2. “STATgram” for Infergen, a hepatitis C treatment by Kadmon's Three Rivers Pharmaceuticals unit which carries a boxed warning, was false and misleading for all the usual reasons – risk information minimized or omitted, claims hyped and indication broadened. 3. April, 2011: Sent to Forest Laboratories, Inc. In that letter the FDA cited a sales representative’s statements as false or misleading because they promoted "unapproved uses for Savella, [made] unsubstantiated superiority and mechanism of action claims about the drug, and [minimized] the serious risks associated with Savella." 4. May, 2011: Sent to Warner Chilcott (US) because of a video that a sales rep posted on YouTube. Directed by the District Manager. Showed discussion wih physician. Didnt disclose risks.
- Prospective Review : FDA’s Eric Blumberg outlined some of the kinds of steps that, in his view, a company should take to prevent off-label marketing: Give written notice to the marketing and sales force that off-label promotion will result intermination of employment as well as reporting them to the FDA and OIG. Require all marketing and sales personnel to periodically file reports with a designated officer stating whether they have personally engaged in off-label promotion or are aware of such conduct by others. Failure to file reports or filing false reports would be grounds for termination. Employment contracts should include a requirement that commissions resulting from off-label promotions will be deducted from any payments made upon termination. Background checks should be performed on anyone seeking sales or marketing positions, and no one who has been excluded from government programs or who was engaged in off-label promotion at a previous job can be hired. Establish a company hotline for reporting instances of off-label promotions; notify employees and physicians about the hotline. Formally monitor sales and marketing operations, including detailing speaker events, promotions, and publications. When a CEO or other responsible corporate officer is informed that off-label promotion has occurred, order a halt to all such promotions until they have been reviewed and stopped. Corporate Actions that may help : Was a comprehensive internal compliance plan in effect, one that could and should have prevented the wrongdoing or uncovered it promptly? When the wrongdoing was uncovered, were effective steps taken to end it immediately and mitigate any real or potential harm? Was any required reporting to the government done, and any restitution of money made to government health benefit programs? As appropriate, were physicians and patients notified? Were effective steps taken to prevent the same wrongdoing from re-occurring? Were these duties within the purview of a “responsible corporate officer”? If so, were they properly and timely carried out? And if not, why not?