• by: |
  • 06/15/2012
The passage of the Prescription Drug User Fee Act (PDUFA) has stalled.   The generic drug industry, along with AARP, trade unions and some other organizations support a provision that they claim would simply require " brand-name drugmakers to provide samples of their medicines, including biologics. Generic drugmakers and their allies, including some insurers and pharmacy benefit managers, complain that brand-name drugmakers have been using the strict distribution provisions of the Risk Evaluation and Mitigation Strategies ( REMS) regulation as an excuse not to provide samples for development and testing."  

And the generic industy says that as a result drug companies are costing consumers and taxpayers billions.

That's the spin.   It's not about the samples.   It's about getting around REMS.  Generic companies never guarantee that they will replicate the REMS system that an innovator comany uses.    Anyone who has seen the citizen's petitions of the generic companies knows that.   So does the FDA.   Take the the case of Accutane (the acne drug that goes by the generic name of isotretinoin):  Despite a  program designed to limit fetal damage from the drug called iPLEDGE there were 122 pregnancies just in its first year.   And that was with just one program. 

By allowing "samples"  the provision would force FDA to approval countless versions of REMS programs that were designed for a single drug for a single use for a specific group of patients.   And now, because the Supreme ruled that innovator companies are liable for harms done to patients by the administration of a generic version of their drug  (Wyeth v. Levine)   any screw up because of a sloppy REMS or the purchase of a product outside the REMS or even an adverse event could be ground for suing an innovator.  

Finally,  it's not just giving samples.  Especially when it comes to the little things, like say, permanent birth defects, maybe we want to be a bit more careful.  Perhaps we want to be extra cautious about passing around samples without having a good reason to go outside a tightly controlled method of distributing and administering a specific group of drugs that has protected infants from damage up till now?   REMS are not one size fits all to be sure.  But take a look at this video about the effects of thalidomide before assuming that there's no risk in giving generic companies every sample of every drug they want.   I find it ironic that the same interests who demand more regulation of innovator companies for the sake of safety are willing to let safety slide for the sake of generic industry profits... 



Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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