According to a story from CNNMoney, Scott Gottlieb, the current commissioner of the US Food and Drug Administration (FDA), said that he plans to curtail high drug prices and go after companies that he believes are “gaming the system.”
Additionally, Gottlieb says that he wanted to streamline the approval process for generic and biosimilar drugs. These statements were made in a recent interview with Kaiser Health News. A major problem for generic and biosimilars is that many “brand name” drug companies use legal loopholes and underhanded strategies to prevent these drugs from reaching approval, which reduces competition and can also serve to keep prices high. These high prices have started to become a major problem for patients, especially for people with long term, rare diseases. Treatments for them can often cost in the hundreds of thousands of dollars.
Despite his declared intention to reduce high drug prices, Gottlieb claims that he wants prices to be determined by the free market. He hopes that plans to increase the approval of generics and biosimilars will help drive down prices by providing more competition for brand name drug companies. Technically, generics are free to compete with brand name drugs once the initial patents have expired, but meddling from brand name companies is constraining the approval of generics.
This meddling typically involves withholding the sale of samples to generic companies, who are expected to thousands of brand name samples in order to develop the generic version and conduct sufficient testing. A possible solution would be to allow generics to buy samples from the EU, but this currently requires studies to prove that drugs from Europe are identical to the equivalent from the US; this is all despite the fact that drugs sold in the EU and US are often made at the same plants.
Under Gottlieb’s management, the FDA has been approving new drugs at a rapid pace, including treatments for rare diseases such as Batten disease. A record total of 46 new drugs were approved last year. The FDA has not escaped criticism for this however, with some questioning the quality and effectiveness of recently approved treatments. Cancer drugs have been subject to even greater scrutiny.
While the success of his efforts has yet to be seen, any attempts to reduce drug prices would be a welcome move by many people, particularly in a health system that has become a progressively more challenging financial burden for the people who need it the most.