Gottlieb confirmed as FDA Commissioner

The U.S. Senate confirmed Scott Gottlieb, M.D., as FDA Commissioner on May 9, 2017 in a 57 to 42 vote, with all voting Republicans and five Democrats voting for confirmation, and all remaining Democrats voting against confirmation. Gottlieb’s ties to the investment company, New Enterprise Associates (NEA), were discussed at length during contentious confirmation hearing; nevertheless, he was easily confirmed. Sen. Lamar Alexander (R-Tenn), who chaired Gottlieb’s confirmation hearing, opined that new Commissioner “will help American families benefit from the promise of 21st Century Cures.”

Gottlieb most recently served as a resident fellow at the conservative American Enterprise Institute (AEI), clinical assistant professor at New York University School of Medicine, and a member of the HHS Federal Health IT Policy Committee. He served as Deputy FDA Commissioner in the George W. Bush administration from 2005 to 2007.He is known for encouraging a quicker FDA approval process for new drugs, with a focus for shortening wait times on large, clinical trials (see Trump nominates Gottlieb for FDA Commissioner, Health Law Daily, March 13, 2017). During his April 5, 2017 confirmation hearing, Democratic senators expressed concern about his financial ties to pharmaceutical and medical device companies (see Gottlieb’s ‘financial entanglements’ troubling or heartening, depending on the senator, Health Law Daily, April 5, 2017). Gottlieb acknowledged the importance of impartiality and told Senators, “I want to earn and keep the public’s trust.”

Trump nominates Gottlieb for FDA Commissioner

President Trump intends to nominate Scott Gottlieb, M.D., a resident fellow at the conservative American Enterprise Institute (AEI), clinical assistant professor at New York University School of Medicine, and a member of the HHS Federal Health IT Policy Committee, to the post of FDA Commissioner. The White House announced the nomination, which brought varied reactions from opposite sides of the aisle and a general positive response from the pharmaceutical industry, via a tweet from Press Secretary Sean Spicer.

Gottlieb served as the Deputy FDA Commissioner from 2005 to 2007 and previously served as a senior official at CMS. He has testified before Congress on numerous occasions as an AEI felllow, most recently with respect to EpiPen® price increases and “How Regulatory Barriers Inhibit Pharmaceutical Competition.” Gottlieb noted that FDA regulatory policy has made developing less expensive copies of complex drugs after patent expiration difficult, discussed how the 340B program has put “upward pressure on drug prices,” while noting other change in drug insurance coverage structure, and described obstacles to competitive single source drug pricing.

Various sources report that Gottlieb has close ties to the pharmaceutical industry. Scientific American noted that Gottlieb believes in a quicker approval process for new drugs, but has focused on shortening waiting times for large, clinical trials rather than doing away with efficacy considerations. He commented on this, to an extent, in remarks he made at the 21st Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) in May 2016.

Gottlieb has also issued commentary about the Patient Protection and Affordable Care Ac (ACA) (P.L. 111-148). In May 2016, he testified before Congress that the law’s tiered marketplace approach has aided consumers with plan selection, but has forced insurers into narrow design corridors. His testimony regarding the ACA also included a suggestion that CMS move away from mandates and towards incentives to encourage individuals to enter into the insurance market (see Is there a better way than the ACA? Hearing asks experts, Health Law Daily, May 12, 2016). More recently, he coauthored a piece with another AEI fellow, opining that President Trump’s election provided, “a generational opportunity to pursue a new direction for American health care” and making suggestions about how a new health care system should operate. The authors suggested that the system should provide a path to catastrophic health insurance for all, accommodate individuals with pre-existing health conditions, allow access to health savings accounts, and deregulate the medical services market.

Senator Lamar Alexander (R-Tenn), Chairman of the Committee on Health, Education, Labor & Pensions, touted Gottlieb’s “impressive qualifications” in a released statement. His colleague, Ranking Member Patty Murray (D-Wash), expressed “initial concerns” about the nomination, including Gottlieb’s “work with multiple pharmaceutical companies, medical device companies, and investment firms.”

Acting CMS, HHS, FDA administrators hold significant agency experience

In the early days of the new presidential administration, interim and acting heads of HHS, CMS, and FDA hold the power pending the finalization of the new leaders. Norris Chochran, Dr. Patrick Conway, and Dr. Stephen Ostroff hold their positions after Secretary Burwell, Acting Administrator Andy Slavitt, and Commissioner Robert Califf, stepped down as President Obama handed over the reins to President Trump. These leadership positions are under extreme scrutiny as legislators push for repealing and replacing the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148).

HHS

Acting HHS Secretary Norris Cochran has served the federal government for two decades, starting at the Centers for Disease Control and Prevention (CDC) in 1996. Cochran is currently the Director of the HHS Office of Budget, overseeing a large staff on budget formulation, execution, and policy, while supporting various budget and financial officials in their duties.

CMS

Dr. Patrick Conway is now the acting administrator of CMS, as well as the Deputy Administrator for Innovation and Quality. In these roles, he oversees Medicare, Medicaid, the Children’s Health Insurance Plan (CHIP), and the marketplaces, while also leading the Center for Clinical Standards and Quality (CCSQ) and the Center for Medicare and Medicaid Innovation (CMMI). Conway was previously Director of Hospital Medicine at Cincinnati Children’s Hospital and served as Chief Medical Officer at the HHS Office of the Assistant Secretary for Planning and Evaluation (ASPE).

FDA

Dr. Stephen Ostroff, is now serving his second stint as acting Commissioner of Food and Drugs. Before joining the FDA in 2013, in roles involving food safety, nutrition, and veterinary medicine, he served as Deputy Director of the National Center for Infectious Diseases at the CDC. In 2014, he served as the FDA’s Chief Scientist, then was the acting commissioner from April 2015 to February 2016, before serving as the Deputy Commissioner for Foods and Veterinary Medicine.

Seems like smooth sailing for Califf’s FDA nomination

Dr. Robert Califf, President Obama’s nominee to be the Commissioner of the Food and Drug Administration (FDA), coasted through questions at a confirmation hearing Tuesday in front of the Senate Health, Education, Labor and Pensions (HELP) Committee. Although many thought the process may hit a few bumps due to his ties with the pharmaceutical industry, Republicans and Democrats alike seem to support his candidacy and the nomination seems expected.

Califf’s background

A cardiologist and clinical trial expert from Duke University, Dr. Califf has been a consultant to drug companies and ran a research institute that received a majority of its funding from the industry. Dr. Califf said in his prepared statement that we need “an unbiased FDA that can work with industry to advance critical technologies while still making independent determinations to ensure that scientific potential is translated into safe and effective products. To advance, we must find common ground with industry and academia on the science without compromising this fundamental role of the FDA.”

Califf’s ties to the industry raised concerns among some public health groups and some Democrats say that he is too close to the industry he is being called on to regulate. Many medical experts dispute that, saying that industry is a principal funder of research in the United States and that working with companies does not present an inherent conflict.

Although essentially friendly, the hearing was punctuated with a few skeptical questions from Senators Elizabeth Warren (D-Mass) and Bernie Sanders (I-VT), who is running for the Democratic presidential nomination. In response to questions from Warren, Califf told the committee that the clinical trials he conducted at Duke, if funded by a drug company, had “ironclad” contracts giving the investigators the final rights to publication. Sanders said aid that the FDA needs a candidate who can stand up to an industry that has been “ripping off” the American people by charging “outrageous” prices for medicines.

Vote

The HELP committee will vote on whether to approve Califf’s nomination, which must then be approved by the full Senate. Patient groups and medical associations are hoping that Califf will help to speed new drugs to market and have publicly supported Califf.