The nation’s new head of the Food and Drug Administration (FDA), Dr. Scott Gottlieb, is a 44-year-old physician, cancer survivor, and a resident fellow at the American Enterprise Institute, with financial ties to the pharmaceutical industry. His ties to the pharmaceutical industry are a big concern for consumer advocates.
What can we expect from Dr. Gottlieb? He has said that he wants to focus his energies on opioid overdoses, from which 91 Americans die every day. But, he has little ability to address this issue since the FDA cannot keep doctors from prescribing opioids.
He has also argued that the FDA needs to give patients access to drugs more quickly through a process called “conditional approval.” This process would allow people to get drugs that had proved safe in Phase 1 trials only. Health care expert, Shannon Brownlee, sees these approvals as undermining patient safety. As it is, nearly one in three drugs that make it through Phase III clinical trials and are approved have been found to be safety risks to patients.
Gottlieb suggests that he wants to see a speedier FDA approval process of generic drugs as a way to bring down drug prices. But, that requires adequate FDA staff, and President Trump has proposed steep budget cuts to administrative agencies. Gottlieb also wants to change the FDA rules for approval of generic biologics. Today, the FDA rules make it difficult to approve generic versions of costly biologics, which treat cancer and autoimmune diseases, keeping their prices sky high.
Gottlieb does not support Trump’s proposal to allow the importation of drugs from Canada and other countries as a way to bring down drug prices. He claims it won’t work.
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