Opioid Addiction is America’s Public Health Challenge
The medical Doctor nominated to head the US Food and Drug Administration (FDA) told Senators last Wednesday that his 1st priority would be tackling the opioid crisis, and he pledged that science will prevail at the agency despite his extensive financial ties to medical companies it regulates.
But Dr. Scott Gottlieb, 44 anni told a Senate health committee that as a cancer survivor, he knows firsthand the importance of “what the FDA does for every one of us” and promised to “lead the FDA as an impartial and passionate advocate for public health.”
He stressed the balance between speeding new products to market and making sure that good science continues to guide the FDA’s decisions.
“We should reject a false dichotomy that it all boils down to a choice between speed and safety,” Dr. Gottlieb said. At the same time, “we need to make sure we’re getting the most bang for our regulatory buck,” he added.
Dr. Gottlieb said opioid addiction is “the biggest crisis facing the agency” and as serious a public health challenge for the entire government, not just FDA, as infectious diseases like Ebola or Zika. He said tackling the crisis would be his 1st priority and will “require dramatic action,” including finding ways to spur development of non-addictive alternative painkillers as well as addiction treatments.
Dr. Gottlieb, is no stranger to the FDA, which regulates products that affect about a quarter of all consumer spending — everything from new drugs and medical devices to food safety, nutrition labeling, tobacco and e-Cigarettes, animal drugs and cosmetics. He was a Deputy Commissioner under President George W. Bush.
“My hope is that you will help move the agency forward so that America’s patients benefit from the remarkable discoveries our nation’s researchers are working on,” said Sen. Lamar Alexander, (R-TN), who chairs the Senate Health, Education, Labor and Pensions Committee.
In ethics documents filed last week, Dr. Gottlieb said that if confirmed as FDA’s commissioner he would recuse himself for a year from decisions involving about 20 companies, including drug giant GlaxoSmithKline (NYSE:GSK), and would resign positions including as a board member or consultant with nine other health-related companies.
Dr. Gottlieb also is a resident fellow at the conservative American Enterprise Institute, from which he said he also would resign.
On drug pricing: Dr. Gottlieb said it was time to adjust FDA policies that make it difficult to quickly approve lower-cost generic versions of certain treatments, particularly drug-and-device combinations.
On the FDA’s food side: Dr. Gottlieb deferred questions about advice on seafood consumption during pregnancy, GE (genetically engineered) Salmon and new nutrition labels set for next year, saying he needed to hear from FDA’s scientists and staff.
Have a terrific week.