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As Congress struggles with healthcare reform, Gottlieb’s FDA is taking action

Written by: | JKamp@wileyrein.com | Dated: Tuesday, August 1st, 2017

John Kamp is Executive Director of the Coalition for Healthcare Communication

 

While the nation’s media has been focusing on the unsuccessful attempts by Republicans to pass a successor to Obamacare, a fascinating sideshow has developed in nearby White Oak, Maryland, home of the Food and Drug Administration (FDA).

Dr. Scott Gottlieb was sworn in as the 23rd Commissioner of Food and Drugs on May 11, 2017. Gottlieb is a physician, medical policy expert, and public health advocate who previously served as the FDA’s Deputy Commissioner for Medical and Scientific Affairs and before that, as a senior adviser to the FDA Commissioner.

Although Gottlieb easily was confirmed by the Republican-controlled Senate, his confirmation hearings were laced with tough questions, especially by Democrats, aimed not at his government experience, but at his years as an industry player, both as an adviser to many companies, and as an investor and entrepreneur in businesses he now regulates.

Detractors worried that Gottlieb was too close to FDA-regulated industries to effectively rein in and regulate them in the public interest. The past three months have proven these detractors wrong.

Since early May, we have witnessed a whirlwind of activity at the FDA with policy announcements emanating almost daily, demonstrating both the limits and the extent of the agency’s power to affect matters of major importance to the medical and larger community.

Consider just four examples:
1. Aggressive action to address the opioid epidemic by demanding more education of doctors who prescribe them and jawboning Endo Pharmaceuticals to withdraw Opana ER from the market.
2. Serious deregulation of many digital devices to spur innovation, lower prices and speed products to market.
3. Modernization of the generic approval process to not only speed approvals but also to highlight for the market the existence of generics with little or no competition.
4. A full-scale reshuffling of the FDA’s focus on regulation of tobacco products, taking advantage of new legislative authority to reduce smoking and its effects.

 

Opioids

On June 8, the FDA requested that Endo remove its opioid pain medication from the market, saying that the benefits of the drug no longer outweighed the risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from the market due to the public health consequences of abuse.

“We are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” said Gottlieb. Endo initially resisted, but did voluntarily withdraw Opana ER several days later.

 

Digital Device Plan

On June 15, Gottlieb announced in a blog post a new Digital Health Innovation Plan focused on fostering innovation at the intersection of medicine and digital health technology.

Gottlieb noted that last year there were 165,000 health-related apps available for Apple or Android smartphones. From mobile apps and fitness trackers to clinical decision support software, innovative digital technologies have the power to transform healthcare in important ways. The Innovation Plan will enable more devices to be marketed without approval and many others to be approved with minimal FDA oversight.

 

Generic Competition

On June 21, Gottlieb announced a new Drug Competition Action Plan and then keynoted a high-profile public meeting on July 18 that focused on ways to not only speed up the generic approval process at FDA but also “to solicit input on places where FDA’s rules … are being used in ways that may create obstacles to generic access, instead of ensuring the vigorous competition Congress intended.” Meanwhile, the FDA announced the creation of a new list of approved generic drugs that have little or no competition, with the expectation that doing so would encourage additional companies to compete and lower consumer prices.

 

Tobacco Regulation

Perhaps the most dramatic announcement came on July 28, when the Commissioner announced a new comprehensive plan for tobacco and nicotine regulation “that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death. The approach places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts.” The FDA is authorized to be aggressive on tobacco through the newly passed Family Smoking Prevention and Tobacco Control Act.

One index of the power of the initiative is the reaction of Wall Street. Per the Financial Times, following the FDA announcement shares in British American Tobacco fell 7 percent and Altria lost 10 percent, wiping about $25 billion from the combined market value of the two companies, the two biggest in the United States.

So, while the White House and Congress struggled over major healthcare issues, the FDA took decisive actions. None will deliver healthcare reform of the magnitude of Obamacare and proposed Republican alternatives, but these actions prove that a dedicated Commissioner of the FDA can – and in Gottlieb’s case will – make incremental changes to the healthcare system that will affect the health of millions of U.S. citizens.

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