Proposed FDA Commissioner Testifies Before Congress

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 04-06-2017 09:29


Scott Gottlieb, MD, the nominee for US Food and Drug Administration (FDA) Commissioner, testified before Congress in a hearing before the Senate Health, Education, Labor and Pensions Committee held in early April 2017. Dr. Gottlieb addressed questions the generic drug approval process, the opioid addiction crisis, and his former work as both a consultant and employee of pharmaceutical and biotech companies.

In the area of generics, Dr. Gottlieb noted that a particular challenge that the FDA faces is advancing high-value generics, or complex generics, through the approval process. due to the difficulty of demonstrating substantial equivalence using traditional bioequivalence and bioavailability studies. He supported the push for the FDA to establish a scientific process that can prove the interchangeability of these drugs. On the related challenges in the biosimilar approval process, Dr. Gottlieb asserted that he would ensure the FDA implements biosimilar guidances in a timely fashion to facilitate market opportunities for competition.

On the opioid addiction crisis, Dr. Gottlieb acknowledged that the FDA will need to re-evaluate whether the agency has the adequate authorities, resources, and policy framework for dealing with this epidemic. As part of his strategy, the FDA would need to look at alternatives to the current application of opioid drugs, in particular, explore the use of medical devices that can provide localized therapy of opioids, thereby potentially changing the safety and benefit of the drug. Also as part of his strategy, Dr. Gottlieb is evaluating the addition of medically assisted therapy in a patient’s regimen after they have become addicted.

Addressing concerns over his prior industry work experience, Dr. Gottlieb assured that Senate Committee if he is confirmed into the position of FDA Commissioner, he would comply with federal rules and recognizes the importance of maintaining impartiality in this role, which includes carrying on continued discussions with ethics officials at the US Department of Health and Human Services and the FDA.

Source: US Senate Committee on Health, Education, Labor and Pensions


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