FDA Names Drugmakers Accused Of Blocking Generics

Marco Green
May 18, 2018

To view the entire list and the FDA's statement, visit the page here. With the FDA's new webpage, which names the makers of more than 50 brand-name drugs that are under scrutiny, it seems they are delivering on that promise.

"We're taking these steps today because we believe greater transparency will help reduce unnecessary hurdles to generic drug development and approval", Gottlieb said. Revlimid, which costs more than $100,000 a year, had sales of $8.19 billion in 2017. It had another eight complaints about another hypertension drug, Opsumit.

In addition to Celgene, Swiss drugmaker Actelion, which was bought by Johnson & Johnson a year ago, had 26 inquiries on four drugs.

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

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

The new disclosures are part of the plan President TrumpDonald John TrumpGiuliani says Federal Bureau of Investigation may have placed spy in Trump campaign Giuliani: There is "nothing illegal about looking for dirt on political opponents" Giuliani: If Mueller subpoenas us, we will challenge it MORE announced last week to lower drug prices.

The FDA published the names of dozens of companies that have potentially been blocking access, saying sunshine is need to change their behavior.

The summary list of allegations-which FDA notes have not been investigated or confirmed-includes situations in which companies have voluntarily limited distribution and situations in which the FDA has imposed limitations as part of the Risk Evaluation and Mitigation Strategy (REMS) program. Even when they are, the agency wants generic companies to have access.

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

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

FDA Commissioner Scott Gottlieb said a generic manufacturer typically needs 1,500 to 5,000 units of the brand drug to perform the tests needed to win regulatory approval of their products, yet more than 150 generic drug developers have complained to the agency about tactics that shut them out. "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". While the bill has bipartisan support, it hasn't become law.

Other reports by Click Lancashire

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