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FDA publishes list of drug companies that may 'game' the system

FDA publishes list of drug companies that may 'game' the system

FDA was requested by the Generic-drug companies for assistance in receiving samples of a variety of drugs from those companies, including cancer, HIV and rare disease drugs.

Johnson Johnson's Actelion Pharmaceuticals, Celgene, and Gilead Life Sciences are all potentially blocking generic drug makers from accessing samples of their products, along with three dozen other drug companies - according to new data out Thursday from the FDA meant to publicly shame them for what it calls "gaming tactics". In others, brand-name drug companies use contracts with distributors and wholesalers to limit distribution of their drugs. The FDA also posted 21 safety determination letters to branded drug companies that said that there was no reason why generic manufacturers couldn't obtain branded drug samples.

"This is a great day for patients, since the administration's list makes the definitive case why brand-name drug companies must stop blocking generic competition", said Allen Goldberg, vice president of communications for the Association for Accessible Medicines, the generic-drug lobby. Those are also disclosed. Celgene received four letters regarding Revlimid, as well as another two for Thalomid.

Celgene, which makes drugs to treat cancer and immune-inflammatory diseases, was named as the subject of 31 inquiries from companies seeking access to Revlimid (lenalidomide), its treatment for multiple myeloma and related diseases; Pomalyst (pomalidomide); and Thalomid (thalidomide). It had another eight complaints about another hypertension drug, Opsumit.

They may cite the presence of a Risk Evaluation and Mitigation Strategy (REMS) - a program the FDA applies to certain drugs to ensure their benefit outweigh their risks - to refuse distribution, or impose conditions on sales that generic makers can not meet. "We hope that this increased transparency will help reduce unnecessary hurdles to generic drug development and approval". "The FDA is taking new steps to address this issue".

"I want to be very clear: a path to securing samples of brand drugs for the goal of generic drug development should always be available". "Even in the case of limited distribution programs such as those required by certain REMS, there should be a path forward for generic drug development".

Drug companies are free to charge whatever they want for their products.

FDA publishes list of drug companies that may 'game' the system

The FDA is planning to update the lists semi-annually.

In an announcement singling out Celgene, Johnson & Johnson subsidiary Actelion and Gilead Sciences among others, FDA Commissioner Dr. Scott Gottlieb said the agency had heard that pharmaceutical companies are engaging in tactics to forestall generic drugs from hitting the market.

Congress has also looked at legislation to crack down on these tactics.

"Without these samples, generic drug makers may not be able to develop generic alternatives".

A spokesman of PhRMA, Andrew Powaleny, said, "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". It was dropped from the Bipartisan Budget Act in February under heavy pressure from the brand-name pharmaceutical industry.

"It is important to differentiate between those products for which FDA has received complaints as opposed to those products for which it has received a request for a safety determination letter", PhRMA continued.

Novartis spokesman Eric Althoff said the company disagrees with the inclusion of its medicines on the list and, as a maker of generic drugs through its Sandoz unit, supports the development of generic products. "Additional context is essential and we believe the Agency should give innovator companies the opportunity to submit their appropriately redacted response to the recipient of a safety determination letter".

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