Regulatory Focus™ > News Articles > Study Calls for Changes to FDA Treatment of Generic Competition

Study Calls for Changes to FDA Treatment of Generic Competition

Posted 11 April 2012 | By Alexander Gaffney, RAC 

Researchers have published a new study in the medical journal Archives of Internal Medicine, in which the researchers argue consumers are being short-changed by US Food and Drug Administration (FDA) regulations that promote excessive reformulations and stymie generic substitution, reports various sources.

To illustrate their point, the authors, led by Dr. Harlan Krumholz of Yale University, studied the effect of reformulations on pharmaceutical manufacturer Abbott Laboratories's cholesterol drug TriCor (fenofibrate).

Krumholz's team argues the lack of generic competition cost consumers an additional $700 million per year, reports Pharmalot.

The company's aggressive legal actions, including patent infringement lawsuits, successfully delayed generic competition while simultaneously making dosing changes to trigger new extensions of patent exclusivity, reports Med Page Today.

None of which is particularly new, surprising or anything but legal, but simply serves to illustrate the main contention that FDA needs to implement "small changes" to prevent companies from coming to rely on the tactics, the authors note.

To that end, the authors make three suggestions:

  • allow generic substitutions for bioequivalent drugs, even if the dosing is different
  • require companies to settle patent disputed before any dosing changes are approved
  • make companies brand and market reformulated drugs differently than the innovative drug

Read more:

Med Page Today - Abbott's Tactics Delayed Generics, Docs Charge

MedScape News - Pharmaceutical Company Strategy Blocks Generic Drug Makers

Pharmalot - When Reformulations Are A Really Bad Deal

Fierce Pharma - Should FDA change its rules to prevent another Tricor?

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