FDA shames companies accused of blocking generic drug development

A view shows the U.S. Food and Drug Administration headquarters in Silver Spring

A view shows the U.S. Food and Drug Administration headquarters in Silver Spring Maryland

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The Food and Drug Administration (FDA) is taking what, for an agency that's generally known for its caution and under-the-radar regulatory approach, may be seen as an aggressive new tact against drug makers: Publicly calling out companies accused of delaying the entry of cheaper generic drugs to the market by preventing generic manufacturers from getting samples of expensive brand name medicines.

"In general, generic drug developers need the samples of the brand drug to develop their generic product and/or to conduct testing to show that their product is bioequivalent to the brand drug for FDA approval", he explained.

Gottlieb also said FDA is notifying the Federal Trade Commission about the inquiries, and encouraged generic companies to raise the cases with that agency, which polices anticompetitive behavior in the pharmaceutical industry. The move is the latest Trump administration action to address high drug prices.

"We hope that this increased transparency will help reduce unnecessary hurdles to generic drug development and approval", Gottlieb said in a statement. Drugmakers say that can't sell them to generic companies because those competitors have not agreed to the REMS limits.

The FDA has followed through on plans to identify pharma companies they believe have tried to block generic copies of their brands, for example by making it hard to acquire medicines for bioequivalence studies.

The FDA said companies are using a variety of tactics to stall the sale of generics. "The inability of generic companies to purchase the samples they need slows down, or entirely impedes, the generic drug development process - leading to delays in bringing affordable generic alternatives to patients in need".

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The drug with the most complaints was Actelion's Tracleer, a drug for a rare condition that causes high blood pressure in the lungs, called pulmonary arterial hypertension.

"While we must continue to foster a competitive marketplace, PhRMA is concerned that FDA's release of the "inquiries" it has received lacks proper context and conflates a number of divergent scenarios".

Greg Geissman, a spokesman, said via email that "These therapies are subjected to rigorous safety controls that have been developed by the company and approved by the FDA". Some of the products in the new list are indeed subject to those program limits - but some aren't at all, the FDA said.

Federal drug regulators identified dozens of drug companies they say have used tactics to try to prevent generic versions of their drugs from being produced, including two of the biggest pharmaceutical companies in MA, in an effort the FDA says contributes to high drug prices.

"All the scheming and exploitation of our government's rules means more profits for corporations at the expense of everyday Americans struggling to get the lifesaving medicines they need".

The Pharmaceutical Research and Manufacturers of America (PhRMA), a trade group for brand-name drugmakers, pointed out in response that more than 90% of prescriptions filled in the USA are for generics.

The Dow companies were listed among dozens of generic and brand-name drugmakers about which complaints have been filed for refusing to provide samples of their products to generic drugmakers wanting to make copies of the brand-name drugs. Despite support from both sides of the aisle, the bill is being held up amidst great opposition from drug companies.

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