This week, the Washington Legal Foundation (WLF) will be hosting a webinar entitled, "Good Manufacturing Practice Deficiencies: Federal Health Care Enforcers' Next False Claims Act Target?" The live webcast will be hosted Thursday, June 13, 2013 from 10:00 a.m. – 11:00 am. EST. To register, click the link above.
As we previously noted several months ago, the federal government, including the Food and Drug Administration (FDA) and the U.S. Department of Justice (DOJ) have indicated an increased likelihood of bringing actions against drug manufacturers for violations of current Good Manufacturing Practices (cGMP) regulations. There has also been speculation that in addition to bringing criminal or civil fines and other administrative penalties against companies for cGMP violations, the federal government might also bring claims against companies under the False Claims Act (FCA).
Essentially, one theory the government might argue is that a drug that is not manufactured in compliance with cGMP regulations is adulterated or misbranded. As a result, if the government pays for a drug that is adulterated or misbranded because of a cGMP violation, the company will have thus submitted a "false claim" to the government—since in effect, the government paid for a drug that was not manufactured properly.
Unlike traditional off-label FCA cases, cGMP cases have the potential to bring in even greater fines. For example, in off-label cases, usually the government calculates losses using a variety of methods to estimate the amount of prescriptions the government paid for as a result of the off-label marketing or promotion. Thus, not all uses for off-label will necessarily be a false claim because some may actually have been prescribed any way, without the undue influence of a manufacturer.
With cGMP cases, the situation would be slightly different. Instead of showing what percentage of prescriptions the government paid for that were off-label, the government might only have to show which lots or packages of drugs were misbranded or adulterated because of the cGMP violations, and that may be enough for DOJ or FDA to calculate large damages—even if not every drug or individual unit or lot is adulterated.
Of course, the current "track-and-trace" legislation pending in Congress right now might make it easier for manufacturers to rebut this claim—however the passage of such legislation is not certain and implementing regulations likely will take at least 18 months from Congress' enactment.
Nevertheless, the WLF webinar will examine several recent federal actions and offer ways that companies can minimize the risk of FDA or DOJ enforcement. The presenters will include two partners form the law firm Alston & Bird LLP:
Questions during the webinar can be emailed to email@example.com.