Regulatory Focus™ > News Articles > Report: REMS Preventing Companies From Making Generic Medicines

Report: REMS Preventing Companies From Making Generic Medicines

Posted 23 May 2012 | By Alexander Gaffney, RAC 

The Food and Drug Administration (FDA) Amendments Act of 2007 allowed FDA to institute risk management plans-known as Risk Evaluation and Mitigation Strategies (REMS)-for products with a high probability of misuse or dangerous side effects.

Now, manufacturers of generic medicines are claiming a side effect of the REMS policy is just as dangerous: restrictive REMS policies are preventing them from obtaining samples of medicines they need to make generic copies.

The Washington Post reports the REMS plans in place for some drugs, intended to restrict access to highly addictive or dangerous medicines, "block the flow of drugs to the wholesalers that generic firms rely on for their must-have samples." Instead, the drugs are tightly controlled by the distributor, and may only be made available to hospitals who administer the drug directly to patients.

The practice is garnering attention from the Federal Trade Commission (FTC), the Senate and Connecticut's Attorney General, reports The Washington Post, all of whom are investigating whether the practice is deliberately being used as protection against legitimate competition.

FTC Chariman Jon Leibowitz called the practice "particularly troubling," while Connecticut Attorney General George Jepsen said his office had indications some branded manufacturers were using REMS "as a weapon to blunt the development of generic drugs."

The practice could be curtailed by language within the Food and Drug Administration Safety and Innovation Act (FDASIA), explains The Washington Post, which requires branded drug manufacturers to provide generics manufacturers with samples so long as they adhere to FDA safety regulations.

The House's version of the legislation, the Food and Drug Administration Reform Act, does not the same provisions, and it is unclear whether the legislative language will make it into the final, combined bill.


Read more:

The Washington Post - Generic-drug makers' complaints over brand-name access prompt investigations


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