Cross-posted at’s On the Docket

As Bloomberg News reported last week, Dr. Janet Woodcock, head of the Food & Drug Administration’s Center for Drug Evaluation and Research, told attendees of the FDA/Generic Pharmaceutical Fall Technical Conference that she has ongoing concerns with the level of equivalence between generic drugs and the “branded” drugs on which the generics are based.  Part of her presentation focused on non-therapeutic matters, such as whether generic versions had the same texture as the branded, or were a different size, or smelled/tasted differently.  But she also spoke pointedly about whether generics are therapeutically equivalent to their branded counterparts.  Dr. Woodcock noted that generic drug company personnel have approached her at other conferences and told her of their concerns:

They say, ‘I know there are products out there that aren’t equivalent,’ and typically they’re manufacturing folks,” Woodcock said in her speech. “I’ve heard it enough times from enough people to believe that there are a few products that aren’t meeting quality standards.”

This is not the first time Dr. Woodcock has put the generic industry on notice that some in the physician and patient communities were starting to doubt generics.  Last January at a generic trade group meeting, Dr. Woodcock warned that there was a “rising tide of skepticism” about the equivalence of generic and branded drugs.  FDA and its Office of Generic Drugs seemed to conclude that this perception Dr. Woodcock related was merely their failure to communicate.  FDA thus responded with a multi-million dollar promotional campaign to assure consumers that generic and branded drugs were equally safe and effective. 

As we urged in a 2009 WLF Legal Backgrounder, FDA needs to do more than merely advance the “equivalent” mantra more often and more loudly – a sentiment reflected by Dr. Woodcock’s comments last week.  Patient safety, as well as the credibility and financial health of the drug industry – both generic and branded – would benefit from a more rigorous generic drug review process.  WLF’s publication noted some of the instances where patient communities and drug makers have taken issue with generic products and FDA’s review of them, concerns which persist today.

Some depression sufferers have not only complained to FDA and consumer advocates about the negative effects of being switched from Wellbutrin XL to its generic, they have sued the generic manufacturers (as noted in this Legal Pulse post).  FDA has staunchly defended the bioequivalence of Wellbutrin XL and its generic, but despite stating that it would perform more taxpayer-funded studies on the generics, it has not yet done so.

Epileptics report a range of side-effects, some of them severe, when they are switched from a branded to a generic anti-epileptic drug (AED) or switched from one generic to another.  FDA has firmly expressed its confidence in generic AED, with one official stating that while FDA is “aware that there are reports of breakthrough seizures . . . with the use of generics, [FDA has] seen no credible evidence that the drugs are responsible.”  Regardless of FDA’s stance, plaintiffs’ lawyers are certainly aware of epileptics’ adverse reports, and are on the lookout for clients to sue generic AED makers.

ViroPharma, the producer of Vancocin, the only branded drug to effectively treat a deadly gastrointestinal bacteria, has fought FDA for years to stop its generic drug reviewers from lowering the approval bar for generic copies of treatments which, like Vancocin, are delivered directly to the “site of activity” and remain there.  In 2006, FDA shifted away from the traditional requirement that generics of these locally acting drugs must do “in vivo” human clinical tests and decided to only require test tube dissolution studies, which ViroPharma says does not ensure the generic will be as effective.  How did ViroPharma learn this?  The company heard it third-hand from a Canadian market analyst.  ViroPharma later discovered that in order to alter the approval requirement, FDA adopted a new interpretation of its own regulations.  Where did FDA announce this critically important interpretive change?  In a response to a Citizen Petition filed by another drug maker.  Vancocin’s manufacturer has now sued FDA seeking a declaratory judgment that it violated the Administrative Procedures Act by making this non-transparent change.

Generic drugs account for over 70% of all prescriptions written in the U.S.  Scores of branded drugs of increasing complexity are soon to lose their patent protection and become subject to generic competition.  It is the ideal time for FDA and its overseers to consider whether FDA’s testing sufficiently protects patient safety.  In the least, FDA should responded with more urgency to Dr. Woodcock’s caution this year than it did to her “tide of skepticism” statement in 2009.  More must be done than simply publishing informational ads and asking that pharmacies display government posters assuring consumers that FDA is protecting them.