New FDA Commissioner reveals strategy to drive down drug prices
pharmafile | May 26, 2017 | News story | Manufacturing and Production, Sales and Marketing | FDA, Scott Gottlieb, Trump, pricing
Deregulation, faster access and cheaper drug prices very quickly became the rallying cry for the Trump administration in the life sciences sphere, even before Trump himself took office. With the appointment of Scott Gottlieb to the role of FDA Commissioner earlier this month, a push towards these ends is definitely being felt, with his latest move putting the pricing crisis squarely in the regulator’s sights.
According to Gottlieb, the FDA is currently working on a “drug competition action plan” which is designed particularly to accelerate the approval of generic drugs which face no competition.
Gottlieb told a congressional panel that he aims for the FDA to take a more active role in the pricing of drugs, noting: “While FDA does not play a direct role in drug pricing, we can take steps to facilitate entry of lower-cost alternatives to the market and increase competition. This is especially true when it comes to safe and effective generic medicines.”
This will include reviewing occurrences of ‘pay-to-delay’ practices where the manufacturers of brand-name treatments attempt to halt or slow the journey of a generic equivalent to market. Gottlieb also noted that the Risk Evaluation and Mitigation Strategy at the FDA was being abused by pharma firms.
“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,” he added.
Among other planned strategies, the FDA aims to improve approval speeds for old, generic medications which are delivered via a new or updated system, such as EpiPen generic variants. The regulator will also compile and publish a list of off-patent drugs which have no pressure from generic rivals in a bid to introduce the competition and drive down costs organically.
Gottlieb acknowledged that new legislation will be required to enact any necessary changes to the approval system as it currently stands.
Matt Fellows
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