Published: Fri, May 18, 2018
Business | By Tara Barton

FDA calls out 39 drug companies for allegedly blocking access to generics

FDA calls out 39 drug companies for allegedly blocking access to generics

In a statement made earlier, FDA Commissioner and Trump Adminstration staff member, Scott Gottlieb, says, "We have heard that some drug makers have either refused to sell samples of products with REMS with Elements to Assure Safe Use (ETASU) impacting distribution to potential generic competitors, or have imposed conditions on the sale of such samples that generic companies find hard or impossible to comply with".

The new list, which also includes Novartis, Pfizer, Valeant, and a host of other companies, is part of the Trump administration's efforts to lower prescription drug prices that kicked off with a presidential address Friday.

His top health officials said they plan to move swiftly. "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", the organization said in a statement.

"We hope that this increased transparency will help reduce unnecessary hurdles to generic drug development and approval". Generic companies need somewhere between 1,000 and 5,000 doses of a drug to complete the studies that prove their product is equivalent with the branded one.

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The FDA said it's gotten more than 150 inquiries from generic companies that want help getting access to a branded drug maker's samples. The complaints were divided among three drugs, with 13 instances pertaining to Revlimid, which is also the subject of a legal battle over its intellectual property. Celgene's thalidomide (Thalomid) and Gilead Sciences' ambrisentan (Letairis) had 10 inquiries each.

And sometimes these brand-name manufacturers refuse to provide this access.

Pharmaceutical companies can block access to their brand-name products through tight safety restrictions on how the drugs are distributed.

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. That program is used when the agency wants a drugmaker to keep a closer eye on a drug once it's on the market. For those that are, the FDA will review the protocol the generic company proposes to use to protect the tight distribution and write a "safety determination letter" to ensure the original drugmaker that releasing samples won't violate the REMS. "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". The lobby group PhRMA has argued that it would be a boon for trial lawyers.

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