By Joseph Walker
Scott Gottlieb, the veteran health-care investor and physician nominated to lead the U.S. Food and Drug Administration, has strong backing from the pharmaceuticals industry as he prepares to put his stamp on the agency.
The Senate is expected to conduct a final vote as soon as this week to confirm Dr. Gottlieb's appointment as FDA commissioner.
Dr. Gottlieb is well known by many drug-industry executives. He worked for years as a consultant to companies including GlaxoSmithKline PLC and Vertex Pharmaceuticals Inc., spoke frequently at health-care and investor conferences, and wrote hundreds of essays and op-eds, often advocating for the FDA to approve drugs faster and loosen regulations on off-label marketing.
Dr. Gottlieb favors free-market strategies to bring down drug costs, including by increasing the rate of generic drug approvals at the FDA. He has also questioned the wisdom of allowing U.S. consumers to import brand-name drugs from countries like Canada, where they cost less, in part because of safety concerns -- a viewpoint shared by drugmakers.
"He agrees with the basic concept of the pharmaceutical industry: the need to have drugs come to market quickly, viewing the bureaucracy as necessary but [it] can get in the way of innovation," says Ronny Gal, a stock analyst at Sanford C. Bernstein & Co.
Company officials say they expect Dr. Gottlieb to push the FDA to accelerate its adoption of more-flexible approaches to evaluating new drugs and clinical trials. His experience as a physician and senior FDA official during the George W. Bush administration should help him garner support from the agency's rank-and-file staff to implement his agenda, executives say.
He "sounds like a progressive person who wants to get things done," said Eli Lilly & Co. Chief Executive David Ricks in an interview. "He's got experience in the agency already. He's a doctor and a cancer survivor. Sounds to me like he has a balanced perspective."
Dr. Gottlieb's extensive prior business relationships with pharmaceutical companies have spurred criticism from some Democrats and public advocacy groups. In April, five Senate Democrats questioned Dr. Gottlieb's commitment to fighting opioid addiction because of his work as a paid expert witness for a fentanyl-drug maker later acquired by Teva Pharmaceutical Industries Ltd. Public Citizen, a liberal watchdog group, said that Dr. Gottlieb was "entangled in an unprecedented web of close financial and business ties to the pharmaceutical industry."
Dr. Gottlieb has said he would recuse himself for one year from FDA decisions on more than 20 companies where he has potential conflicts of interest. "I understand how important impartiality of this agency is," Dr. Gottlieb said at his Senate confirmation hearing in April. "I don't want to do anything in my conduct to reduce people's confidence in the agency's mission."
Dr. Gottlieb earned at least $645,000 from drug companies and trade groups from the beginning of 2016 through the first two months of 2017, according to his disclosure statements.
He served for seven years on a GlaxoSmithKline board that manages the company's research and development investments, providing "a valuable perspective on the U.S. health-care and payer environment," said a GSK spokeswoman. As FDA commissioner, Dr. Gottlieb "will help ensure that the FDA maintains its focus on innovation and protecting public health by expeditiously approving safe and effective new treatments for patients," she said.
Dr. Gottlieb has also been supportive of loosening FDA restrictions on off-label marketing, where companies advertise uses for their drugs that haven't been cleared by the agency. He has advocated allowing companies to distribute such information to doctors so long as it is truthful and non-misleading.
There are numerous alternatives to "FDA's current regime -- which virtually bans off-label promotion -- that would promote FDA's public health goals even better than the current regime does," Dr. Gottlieb wrote in expert testimony in 2015 on behalf of Amarin Corp., in a lawsuit the company filed against the FDA over its off-label marketing policies.
Like other of President Donald Trump's nominees, Dr. Gottlieb has been critical of the agency he is nominated to oversee. He wrote in a 2012 essay that the FDA has a "harmful culture" that mistrusts doctors to prescribe drugs appropriately, leading officials to have "an excessive desire for certainty" that new medicines are safe and effective before they are approved, he wrote.
The FDA has several methods for accelerating approvals, such as granting conditional approval if studies show the drug is "reasonably likely" to help patients live longer or have other benefits. Some FDA divisions have embraced the faster methods, but other divisions are still very "rigid," says Ron Cohen, chief executive of Acorda Therapeutics Inc. "Even if you bring them evidence of benefit to patients, it's still an uphill climb."
Dr. Gottlieb said in April that he would create "consistency to how different parts of the FDA" use their powers.
Some researchers question how much further the FDA can go in speeding up drug approvals without lowering its standards. More than two-thirds of drug approvals last year were completed under "priority review," where the FDA makes an approval decision within six months instead of the standard 10 months, according to the FDA.
"The FDA is already one of the fastest regulatory agencies in the world, " says Aaron Kesselheim, an associate professor of medicine at Harvard Medical School. "Faster for faster's sake is not wise."
--Peter Loftus contributed to this article.
Write to Joseph Walker at [email protected]