F.D.A. Chief Goes Against the Administration Stereotype

“He doesn’t want to blow up the agency,” said Mark I. Schwartz, a Washington lawyer who worked at the F.D.A. in Republican in addition to Democratic administrations.

Dr. Gottlieb has briefed Mr. Trump repeatedly on agency issues, like opioids in addition to generic drugs. During a dinner at the globe Economic Forum in Davos, Switzerland, last month, President Trump told a group of European business executives, including a few through the pharmaceutical industry, in which “Scott Gottlieb, as you know, is usually a star.”

So far, the commissioner has displayed a collaborative management style, seeming to allay the concerns of some career employees who had balked at his industry ties in addition to were dismayed by articles he had written criticizing the F.D.A. He has overcome some divisions by promoting several agency veterans, yet he has also hired a few industry insiders for top positions. He is usually described by staff as energetic in addition to intense, while holding town hall-style meetings before doing decisions.


Dr. Jean Rinaldi, left, showing Dr. Gottlieb the cardiac devices laboratory of the F.D.A.’s Center for Devices in addition to Radiological Health in Silver Spring, Md.

Michael J. Ermarth/United States Food in addition to Drug Administration

“He’s being thoughtful; he’s being deliberative,” said William Hubbard, who retired through the F.D.A. after 30 years, including work as a consultant to a former commissioner, Dr. Margaret A. Hamburg, until she stepped down in 2015. “He seems to be putting aside some of his more extreme rhetoric through when he was outside, in addition to working through the issues using a public-health orientation.”

Although Dr. Gottlieb declined to be interviewed because of This specific article, he is usually quite chatty online. He issues lengthy statements after nearly every major decision, in addition to banters on Twitter, chiding reporters for eating unsafe Thanksgiving leftovers or laughing along at jokes about his skinny jeans, or his prized backyard chickens.

“I thought he was a bad pick,” said Andrew Kolodny, a co-director of opioid policy research at Brandeis University. “yet I may have been wrong.”

Dr. Kolodny singled out the agency’s success last summer in getting Endo Pharmaceuticals to stop selling an extended-Discharge opioid, Opana ER, citing its concerns in which the drug’s benefits no longer outweighed the risk of abuse.

Critical decisions ahead

Even as Dr. Gottlieb makes some progress, there are major unsettled regulatory matters before the agency. They include the extent to which drug companies can market their products for off-label uses as well as how much oversight is usually needed for the laboratory-developed tests in which hospitals in addition to doctors often use to detect conditions ranging through heart disease to ovarian cancer — a booming business.

Among the most far-reaching decisions will be the efforts taken to reduce the time for drug companies to develop brand-new drugs.

“in which is usually where anxiety lies,” said Mr. Hubbard, who added in which the key will be ensuring in which, in moving brand-new products to market more quickly, public health is usually not compromised. “The test will be whether he can do in which safely, in addition to we won’t know the results of in which for quite some time.”

Some early decisions have drawn criticism, like postponing requirements for food companies to note sugar in addition to different nutritional information on package labels. Another sparked an outcry when Dr. Gottlieb partly reversed his own position, deciding against disclosing the reasons the agency gives drug companies when the item turns down products.

He has taken steps to speed drug in addition to device approvals, in addition to has promised to do more.

Dr. Michael Carome, director of the consumer group Public Citizen’s health research arm in addition to a former health department official, opposed Dr. Gottlieb for the job, in addition to has not seen anything to change his mind.

“The bottom line is usually This specific: He’s pursuing a pro-industry deregulatory agenda in which ultimately is usually going to put patients at risk,” Dr. Carome said. “The F.D.A. currently views industry as their customers, in addition to they need to keep them happy.”

An industry veteran using a government past

Dr. Gottlieb’s Republican credentials made him a strong candidate for the agency’s top post through the beginning. He had previously worked for both the Department of Health in addition to Human Services in addition to the F.D.A. during the administration of President George W. Bush.

yet his chances were not clear early last year, after President Trump vowed to slash drug regulations in addition to, in an address to Congress, described the F.D.A.’s approval process as “slow in addition to burdensome.” different names surfaced, like Jim O’Neill, an associate of the Silicon Valley billionaire Peter Thiel. Mr. O’Neill had suggested in which drugs could be approved without first proving they worked in addition to supported the creation of colonies at sea in which could be beyond government reach.

Those views made Dr. Gottlieb look mainstream by comparison. So after a hearing in which focused on his ties to the drug in addition to device industry, he was confirmed by the Senate, 57 to 42, on May 9.

Critics pointed to Dr. Gottlieb’s stints on advisory boards for pharmaceutical companies, among them GlaxoSmithKline in addition to Daiichi Sankyo, in addition to his consultant work for others, including Vertex Pharmaceuticals in addition to Bristol-Myers Squibb.

His investments through brand-new Enterprise Associates, a venture capital firm, in addition to T.R. Winston & Company, an investment bank, were also called into question. Earlier in Dr. Gottlieb’s career, before attending the Mount Sinai School of Medicine, he worked as a health care investment banking analyst for Alex. Brown & Sons.

in which experience, Dr. Gottlieb has said, benefits the F.D.A. because the item helps him understand the industry. He has recused himself For two main years through matters concerning about 20 companies with which he was associated — in accordance with the White House ethics pledge. The day he was sworn in, he sold all of his health-related stock, including investments in Tolero Pharmaceuticals, Collective Health in addition to U.S. Renal Care, according to a financial report filed with the Office of Government Ethics. He purchased government bond funds.

Like most of Mr. Trump’s appointees, Dr. Gottlieb has also hired industry lawyers in addition to lobbyists whose former clients often have business before the agency. Among them are Jack Kalavritinos, an associate commissioner who had lobbied for the device maker Covidien, currently owned by Medtronic, for seven years; Nina Devlin, a senior communications adviser who was the head of global communications at Mylan, makers of the EpiPen; in addition to Rebecca K. Wood, who was a partner inside the law firm Sidley Austin in addition to is usually currently the agency’s top lawyer.

According to her financial disclosure forms, Ms. Wood did legal work for many of the drug industry’s largest companies in addition to trade groups, including AbbVie, Bayer, St. Jude Medical in addition to the Medical Information Working Group, which favors the expansion of off-label uses for drugs. She also worked for brand-new Enterprise Associates, in which Dr. Gottlieb was a venture partner. An agency spokeswoman said in which Ms. Wood has had to recuse herself already through several matters, yet declined to detail the issues involved.

A balancing act

By taking a more conventional approach to the job, Dr. Gottlieb stands out among different presidential appointees, some of whom have aggressively rolled back regulations or are curtailing the scope of their agencies’ powers, as at the Environmental Protection Agency in addition to the Department of Energy.

He has already disagreed with an administration position, objecting to a plan to move an international food-safety division to the trade office, saying the item could hurt the country’s reputation as a food watchdog.


An F.D.A. advisory panel recently rejected requests by Philip Morris International to market a brand-new product, IQOS, in which uses a heated tobacco stick, as safer than cigarettes.

Peter Nicholls/Reuters

The administration backed down on the trade matter, yet Dr. Gottlieb has been forced to compromise on different issues. Last October, he questioned proposals backed by Vice President Mike Pence in addition to others in which could give terminally ill patients greater access to experimental treatments. He did make a concession — promising in which the F.D.A. could find a way to make the item easier for patients to get some of those treatments, although he noted in which the agency already approves 99 percent of such requests. Mr. Trump also recently told Republican lawmakers in which Dr. Gottlieb was leading the effort to get legislation passed by Congress.

in which balancing act has also been on display in Dr. Gottlieb’s approach to regulating tobacco. Last July, he sent tobacco stocks into a dive after he vowed to take aggressive steps to render cigarettes nonaddictive by forcing manufacturers to cut nicotine levels.

yet even as he railed against big tobacco, Dr. Gottlieb softened the blow by delaying for several years the deadline for companies to comply with tough brand-new rules on e-cigarettes, cigars in addition to different products.

At the time, he said smokers needed better in addition to more substitutes to get them off nicotine.

yet whether he can maintain in which balance remains to be seen: Last month, an F.D.A. advisory committee rejected a major alternative tobacco product to be considered under the brand-new regulations, saying its supplier received a, Philip Morris International, could not claim the item was safer than cigarettes. The product under review was the IQOS, a heated tobacco stick device in which the company wanted to market as a healthier alternative to cigarettes.

If the industry can’t overcome such hurdles for approval or finds the process too cumbersome in addition to expensive — Philip Morris is usually spending billions of dollars developing smoking alternatives in which could need agency approval — Dr. Gottlieb’s efforts to straddle the division between public health in addition to commerce could be hobbled.

Despite the panel’s rejection — the experts questioned the science behind the product — agency officials were quick to say they could continue reviewing Philip Morris’s studies in addition to could ask for more information.

Kenneth Warner, a tobacco control expert in addition to dean emeritus of the University of Michigan School of Public Health, said he found the item surprising in which the F.D.A. was taking such strong steps to rein inside the tobacco industry. “the item’s somewhat ironic to me in which the item takes a Republican administration to think about a brand-new regulation like in which, in which could have a benefit for public health,” he said.

Congressional Democrats, though, are still smarting through Dr. Gottlieb’s decision to extend the deadline for compliance with brand-new e-cigarette rules, which took effect in 2016. The rules called for companies with products already on the market to disclose their contents in addition to to prove their positive impact on public health in order to gain approval.

Before becoming commissioner, Dr. Gottlieb served on the board of directors of Kure, a retailer in which sells e-cigarette products in lounge-like settings. He has since sold his stake in Kure in addition to said he could recuse himself through any decisions involving the company For two main years.

Tackling public anger over drug prices

High drug prices — in addition to what to do about them — were a frequent topic of the last election, in addition to the Trump administration seems poised to offer some brand-new proposals in its budget.

Here, Dr. Gottlieb has shifted the agency’s position. F.D.A. officials have traditionally said in which regulating prices is usually beyond the agency’s purview. yet Dr. Gottlieb has taken steps to encourage more competition for products in which have lost patent protection, including shortening an agency backlog for approvals of brand-new generic drugs in addition to publishing a list of off-patent drugs for which there is usually no alternative.

He surprised critics by holding up for ridicule brand-name drug companies in which had refused to supply could-be rivals with samples of their drugs to deter generic competition.

“End the shenanigans,” Dr. Gottlieb said at a Federal Trade Commission meeting in November.

The commissioner’s actions so far are likely to do little to substantially lower prices for most Americans, in addition to they notably do not address the towering prices in which brand-name drugmakers set for their products.

Still, Chester Davis Jr., president in addition to chief executive of the Association for Accessible Medicines, which represents generic drug companies, was effusive. “The commissioner has been very effective in using his bully pulpit to shine a very bright light on anti-competitive practices,” Mr. Davis said.

Another closely watched decision will be Dr. Gottlieb’s response to the charged question of how broadly drug companies can market products for unapproved uses. The pharmaceutical industry has won some court cases by arguing in which companies have a First Amendment right to promote products for conditions in which have not been sanctioned by the agency.

Before becoming commissioner, Dr. Gottlieb supported so-called “off label” promotion. He has not yet moved to issue final guidelines, first proposed under the Obama administration, in which will let drugmakers discuss unapproved uses with entities like insurance companies. He has also issued few warning letters to drug companies for deceptive advertising.

Any decision the agency makes worries people like Dr. Joshua M. Sharfstein, who was at the F.D.A. inside the Obama administration. “If the F.D.A. surrenders on First Amendment issues, there could be very serious consequences for the agency’s ability to do its job,” he said.

Senator Murray is usually still concerned about Dr. Gottlieb’s leadership, saying the agency wasn’t doing enough on nutrition or to keep children away through tobacco products. She added in which “the F.D.A. is usually too often focused on doing what’s best for massive corporations, rather than patients in addition to families.”

Senator Elizabeth Warren, Democrat of Massachusetts, was also an early critic, yet she has grown more supportive. “Dr. Gottlieb is usually willing to tackle tough problems,” Senator Warren said. “I let him know when I think he’s got the item wrong, in addition to when he’s got the item right.”

Jennifer Miller, an assistant professor in addition to clinical trials transparency expert at brand-new York University School of Medicine, said a pilot program started off by Dr. Gottlieb, in which pharmaceutical firms voluntarily Discharge information about their clinical studies for approved drugs, was a step inside the right direction.

“The industry is usually already trending toward releasing them,” Dr. Miller said. “the item’s a safe time to roll out a pilot. I think he’ll likely be successful in addition to learn what works in addition to what didn’t.”

Continue reading the main story

Source link

Leave a Reply