The speech trod some territory that will be familiar to those paying attention to President Trump’s pronouncements on the future of the FDA, with efforts to reduce medicine pricing and improve the efficiency at the Agency sitting alongside pledges to reduce smoking rates and tackle the greatest immediate challenge” of rampant opioid abuse. “Too many consumers are priced out of the medicines they need,” said Gottlieb, who was the President’s pick for the FDA’s top job. While he acknowledged that the FDA does not have a direct role to play in setting drug prices, he said it still needs to take “meaningful steps” to get more low cost alternatives to the market.
In particular, he said there is a need to accelerate the availability of complex generics and biosimilars, and to clamp down on anti-competitive practices such as pay-for-delay deals. “We also need to take steps to make sure the generic drug process isn’t being inappropriately gamed to delay competition and disadvantage consumers,” said Gottlieb, adding: “I hope to have much more to say on this topic in the coming weeks.”
Among other actions taken by the new Commissioner is a re-organization of the FDA’s 4,000 Investigators so they focus on a particular product category rather than a geographic area, according to a Bloomberg report, citing an internal FDA memo. The reshuffle of the Office of Regulatory Affairs (ORA) will not result in a reduction in headcount; however, the teams will be re-organized within specialist offices focusing on pharmaceutical quality, medical devices, tobacco, food, biologics drugs including vaccines and research, it says. The FDA’s network of testing labs will also be more focused on product categories under the initiative, which according to the memo was proposed four years ago and was planned to get underway in May 2017.
The shake-up has already been welcomed by Gottlieb’s predecessor Robert Califf, who tweeted: “Aligning inspections with product expertise. Critical for new commish to reinforce ‘program alignment’.”
Gottlieb also acknowledged that some agency staff have expressed feelings of uncertainty at the moment. After all, job security anxiety has been high in the face of Trump’s efforts to pare down federal expenses and repeated albeit vague statements that the FDA needs to improve its “regulatory efficiency”. So far, the Agency has escaped the swingeing cuts directed at the National Institutes of Health (NIH), which were rejected by lawmakers late in April 2017. The President has said he intends rather to raise user fees dramatically to remove the need for additional public funding.
On the issue of regulatory reforms, the new Commissioner said implementing the 21st Century Cures Act is a priority, and that the FDA must ensure it is able to regulate promising new technologies in ways that don’t increase the cost of development or hamstring innovation. “We need to make sure we’re getting the most public health bang for our efforts and the resources that we’re entrusted with,” said Gottlieb, who also said he looked forward to achieving “operational efficiencies that can improve our ability to fulfill our public health mission and protect consumers.”
“I know we only have limited resources to do these hard tasks. And I also know, from my prior work at FDA, how much we accomplish with the limited tools and resources we have available to us,” he continued. “We need to be patient-centric and science-based in everything we do. And, we must make sure that in all our efforts, we maintain the gold standard for regulatory science and independent, science-led decision-making, all led by a strong career workforce.”
REFERENCE: FierceBioTech; 16 MAY 2017; Phil Taylor