FDA Calls Out Drug Makers That Improperly Block Generic Competition

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

Mr. Trump also wants drug companies to disclose the list price of their drugs on TV ads. Some of the products in the new list are indeed subject to those program limits - but some aren't at all, the FDA said.

Others brand companies put restrictions in their contracts with drug distributors, wholesalers or specialty pharmacies to prevent those intermediaries from selling samples to generic makers. 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.

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

"They're using laws to promote public health and innovation to pad their pockets instead", Health and Human Services Secretary Alex Azar said in a speech on May 16. Revlimid, which costs more than $100,000 a year, had sales of $8.19 billion in 2017.

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.

In addition to Celgene, Swiss drugmaker Actelion, which was bought by Johnson & Johnson past year, had 26 inquiries on four drugs. Gilead's had 10 complaints about its own hypertension product, Letairis, and gotten two letters.

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.

PhRMA also pointed out that the FDA approved a record number of generic drugs previous year.

"Efforts to enhance competition in the marketplace for biopharmaceuticals has helped make the United States a global leader in generic prescriptions with more than 90% of all prescriptions filled being generic", the group said in a statement.

"I'm not looking to shame drug companies", Gottlieb said at a breakfast with reporters on May 15.

Numerous about 50 drugs on the FDA's list published on May 17 aren't subject to a REMS.

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. "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".

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". While the bill has bipartisan support, it hasn't become law.



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