US Food and Drug Administration (FDA) Commissioner Scott Gottlieb took questions at the National Press Club in Washington, D.C. on Friday, offering perspective on what the agency is doing to be more efficient, actions related to the opioid epidemic and how FDA plays a role in the drug pricing debate.
In the question and answer section of the talk, Gottlieb noted the agency will be putting forth more guidelines to drive efficiencies in the development of new therapies, particularly with the release of new product-specific guidance documents on neurological disorders and other unmet needs.
On the medical device side, he discussed again the idea of creating a new “total product life-cycle” office under the Center for Devices and Radiological Health, as well as ways to transform clinical trials via modeling and simulation, registries and real-world data.
In terms of drug prices, he noted that FDA has been trying to promote generic competition and further discussed the ways in which some generic drug manufacturers are impeded from entering certain markets, often because of Risk Evaluation and Mitigation Strategies (REMS) that lead to restrictions on their ability to purchase brand-name products to conduct the necessary bioequivalence tests for approval.
He noted that FDA may potentially allow generic companies to go to Europe to purchase drugs for bioequivalence testing.
In response to a question on the use of drug imports to lower costs, Gottlieb noted that no HHS secretary in the past has been able to make the determination that such imports could be kept safe, and he added that the supply chain has become more complex since previous secretaries sought to evaluate such a scenario. However, he said FDA would re-evaluate the use of imports if asked to do so.
As far as the agency’s staffing woes, he said more information will be forthcoming on a pilot project that the agency conducted and that thanks to the 21st Century Cures Act, FDA can make more targeted hires for employees with certain expertise and pay higher salaries if necessary.
One of the challenges is complex products, he said, noting that only a small subset of experts across the country can review them.
On the topic of opioids, Gottlieb noted that the agency is in discussions with provider groups and is looking at steps to better effect how drugs are dispensed, possibly via changes to labels or packaging.
And on the subject of President Donald Trump’s two-out, one-in regulatory policy created under an executive order, Gottlieb noted that a lot of FDA’s regulations are de-regulatory in nature and are scored often as savings.