FDA Commissioner Scott Gottlieb told, during a U.S. House of Representatives budget hearing, that the agency is thinking about a “drug competition action plan” ( soon to be unveiled) aimed at speeding up the approval of generic versions of brand-name medicine that lack competition and at the same time lowerin the prices.
In particular, Gottlieb is calling for the agency to intevene when a by brand-name drug makers uses safety regulations to slow the introduction of generic competition and he said “FDA has an important role to play in preserving the balance between innovation and access and making sure its statutory and regulatory processes are working as intended and not being manipulated in ways that FDA and Congress didn’t intend.” As it happens, according to the commissioner for the Risk Evaluation and Mitigation Strategy, which enables the FDA to require a manufacturer to prove that the benefits of a drug outweigh its risks, which is abused by the pharmaceutical industry.
Scott Gottlieb has also announced that the agency could publish lists of older drugs that are off-patent without generic competitors in order to incitivate potential new market entries and at the same time discouraging the practice of companies acquiring older therapies and then hiking their prices.
He made also the example of EpiPens, an old medication that has a new delivery system: he wants to improve the process for approving generic versions of “complex” drugs such this one.
So even if the FDA can’t regulate drug prices, it can implement measures aimed at increasing competition and ultimately bringing prices down.
Scott Gottlieb has also annouced the he wants the agency to “completely eliminating” a backlog of generic medications waiting for a review (currently stands at 2640 filings), he told members of Congress.
According to Bloomberg firms with lots of new drugs face less risk from this FDA competition action plan, while companies that rely on expensive biologic medicines might have some troubles as “the process for getting a so-called biosimilar approved and on the market is substantially tougher than that for a regular generic. And the small number of biosimilars that have made it to market are not as easy to substitute for the original product”.
Moreover Gottlieb stated that getting biosimilars to consumers is a priority. Always according to Bloomberg analisys if the process will be speeded up then that will have a major impact on some blockbuster drugs. In this case the biggest loser be specialty pharma, companies selling expensive medicines they don’t typically develop in-house.
Source: Bloomberg, The Wall Street Journal
