A Timeline of Dr. Gottlieb’s Brief Tenure at the FDA: 2017-2019

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A Timeline of Dr. Gottlieb’s Brief Tenure at the FDA: 2017-2019

March 8, 2019 by sjwilliamspa

A Timeline of Dr. Gottlieb’s Tenure at the FDA: 2017-2019

Reporter: Stephen J. Williams, Ph.D.

From FiercePharma.com

FDA chief Scott Gottlieb steps down, leaving pet projects behind

FDA Commissioner Scott Gottlieb was appointed by President Trump in 2017. (FDA)

Also under his command, the FDA took quick and decisive action on drug costs. The commissioner worked to boost generic approvals and crack down on regulatory “gaming” that stifles competition. He additionally blamed branded drug companies for an “anemic” U.S. biosimilars market and recently blasted insulin pricing.

His sudden departure will likely leave many agency efforts to lower costs up in the air. After the news broke, many pharma watchers posted on Twitter that Gottlieb’s resignation is a loss for the industry.

During his tenure as FDA commissioner, Gottlieb’s name had been floated for HHS chief when former HHS secretary Tom Price resigned due to a travel scandal, but Gottlieb said he was best suited for the FDA commissioner job. Now, former Eli Lilly executive Alex Azar serves as HHS secretary, and on Tuesday afternoon, Azar praised Gottlieb for his work at the agency.

Gottlieb’s quick goodbye triggers investor panic, biopharma bewilderment and at least one good riddance

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A Timeline of Dr. Gottlieb’s Tenure at the FDA

From FiercePharma.com

New FDA commissioner Gottlieb unveils price-fighting strategies

New FDA commissioner Scott Gottlieb laid out some approaches the agency will take to fight high prices.

During the campaign and since the U.S. presidential election, President Donald Trump has pledged to bring down drug costs and, in some cases, railed against the industry for its pricing. Now, his new FDA commissioner is laying out some approaches the agency will take to fight high prices.

Importantly, the FDA can’t regulate drug prices, but it can implement measures aimed at deterring the types of price hikes that have made so many headlines over more than a year.

At a U.S. House of Representatives budget hearing on Thursday, new FDA commissioner Scott Gottlieb said his agency will publish and regularly update a list of medications that are off patent and have no competition, work to improve generic review times and seek to “curtail gaming” of regulations by the industry that allows companies to extend patent monopolies.

On the first point, Gottlieb said a regularly updated list of off-patent meds could “entice competitors into the market” and ultimately lower costs. One such old, off-patent med with no generic competition is infamous to industry watchers: Daraprim.

Back in 2015, after picking up the medication from Marathon Pharma, Martin Shkreli’s Turing Pharma raised Daraprim’s price exponentially, triggering intense backlash.

In his opening remarks at the budget hearing, Gottlieb said he’s working on a “drug competition action plan” that he will unveil soon. However, the new commissioner did offer a few strategies to lower costs.

The FDA will work to “improve processes that enable generic versions of complex drugs to be approved for marketing,” and simplify the overall generic review process, Gottlieb said. He wants the agency to achieve those goals while “completely eliminating” a backlog of generic medications waiting for a review, he told members of Congress.

Further, the FDA will seek to stop misuse of Risk Evaluation Mitigation Strategies that have hurt generic drug developers’ ability to get samples of branded medications needed to develop copycats.

The proposals will likely be welcomed by those who’ve asked for drug pricing reform but have seen little action from Congress despite more than a year of calls from its members to rein in drug prices.

In a Thursday statement, the pharmacy benefit manager industry group PCMA hailed the proposals.

“As the Trump administration seeks to combat high drug costs, we applaud FDA Commissioner Gottlieb’s decision to publish a ‘watch list’ of off-patent drugs,” PCMA CEO Mark Merritt said in a statement. “This move, which PCMA and others have long advocated, will help deter manufacturers from buying the rights to drugs like Daraprim for the explicit purpose of raising their price.”

UPDATED 3/19/2019

National Cancer Chief, Ned Sharpless, Named F.D.A.’s Acting Commissioner

From the NYTimes

Dr. Norman E. Sharpless was named acting commissioner of the Food and Drug Administration on Tuesday. For the last 18 months, he had been director of the National Cancer Institute.CreditTom Williams/CQ Roll Call, via Getty Images

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By Sheila Kaplan

WASHINGTON — Dr. Norman E. (Ned) Sharpless, director of the National Cancer Institute, will serve as acting commissioner of the Food and Drug Administration, Alex M. Azar III, secretary of health and human services, announced on Tuesday.

Dr. Sharpless temporarily will fill the post being vacated by Dr. Scott Gottlieb, who stunned public health experts, lawmakers and consumer groups last week when he abruptly announced that he was resigningfor personal reasons.

Dr. Sharpless has been director of the cancer center, part of the National Institutes of Health, since October 2017. He is also chief of the aging biology and cancer section in the National Institute on Aging’s Laboratory of Genetics and Genomics. His research focuses on the relationship between aging and cancer, and development of new treatments for melanoma, lung cancer and breast cancer.

“Dr. Sharpless’s deep scientific background and expertise will make him a strong leader for F.D.A.,” said Mr. Azar, in a statement. “There will be no let up in the agency’s focus, from ongoing efforts on drug approvals and combating the opioid crisis to modernizing food safety and addressing the rapid rise in youth use of e-cigarettes.”

Dr. Douglas Lowy, known for seminal research on the link between human papillomavirus and multiple cancer types including cervical, and ultimately leading to development of a vaccine, will be named head of the NCI to replace Dr. Sharpless. Dr. Lowy currently is Deputy Director of the NCI.