FDA head vows drug-cost fight
Aims to end drugmakers’ stalling of less-expensive generics
U.S. Food and Drugs Commissioner Scott Gottlieb said he will do everything he can to fight high drug prices and that he sees drug companies “gaming the system to try to block competition.”
Gottlieb also said he wants to speed up the U.S. approval process for generic and “biosimilar” versions of biologic drugs, which are drugs composed of living organisms, such as plant or animal cells.
“Where we see things that we can address, we’re going to take action,” Gottlieb said in an interview. He said he is most bothered when brand-name companies use tactics to block makers of generics and biosimilars from developing drugs.
“I think we should have a free market for how products are priced,” Gottlieb said. A free market “provides proper incentives for entrepreneurs who are going to make the big investments needed to innovate. But that system is predicated on a premise that when patents have lapsed, you’ll have vigorous competition from generic drugs.”
The Food and Drug Administration, Gottlieb said, worked with the White House on a proposal to bring generics to market faster by ensuring that drugmakers don’t use a 180-day exclusivity period to block competition. He said there are “situations where you see deals cut” in which drugmakers get the 180-day exclusivity and then can be persuaded to sit on it without selling the drugs — essentially delaying the branded drug from facing generic competition.
Currently, generics makers must buy large quantities of a brandname product in the U.S. to run their own clinical trials. But the companies that make brandname medicines, in some cases, are making it very difficult for makers of generics to purchase their drugs, he said.
“They are adopting all kinds of commercial restrictions with specialty pharma distributors and wholesalers” to prevent sales to generic companies, Gottlieb said.
Last fall, Gottlieb said he wanted to “end the shenanigans” that interfere with competition in the marketplace. Since, the FDA has released a steady stream of plans and new guidance that tinkers with the drug-development system.
“All of these steps are going to have an impact, and I don’t think there’s one silver bullet,” Gottlieb said. “If anyone (thinks) there is one thing you can do with policy intervention that is going to dramatically change drug prices, that’s not true.”