The resignation of Scott Gottlieb as commissioner of the Food and Drug Administration raises a big question: Will the policies so publicly advocated by Gottlieb continue after his departure?
Gottlieb has been one of the most communications-savvy administrators the government has ever seen. He tweeted virtually every day as @SGottliebFDA not just to tell the Twitterverse what he was doing but to substantively explain complex policies and to advocate for FDA decisions. Many of his tweets were issued on weekends; you almost see Gottlieb sitting in his home writing and transmitting his tweets.
Gottlieb also issued several hundred “statements” through official FDA channels, covering virtually every policy decision the agency made. He used these statements, sometimes co-authored by another senior FDA official, not only to explain policy but to advance it. There were few issues the FDA was involved in that escaped a tweet, a statement, or both.
An agency like the FDA benefits from transparency and public discussion of policies and regulated products. It touches the lives of every American every day through its regulation of foods, medical products, and cosmetics. Consumers can have greater confidence in these products knowing that if new information arises about a product, or new policies are being considered, the FDA will be transparent about it.
The public policies Gottlieb advocated were well-defined through his tweets and statements. They include the following major themes:
E-cigarette and tobacco regulation. Gottlieb has probably dedicated more tweets and statements to this issue than to any other. He broke new regulatory ground in railing against the use of e-cigarettes, especially by young people, and in seeking new ways to regulate tobacco products.
Facilitating drug approvals. In the past two years, the FDA approved a record number of novel drugs, including new heights for orphan drugs. The agency also set a record in approvals for novel devices. There is more open communication between the FDA medical staff and the pharmaceutical and medical device industries, enabling them to overcome barriers to approvals more quickly.
Generic drug approvals. Gottlieb viewed expediting the approval of generic drugs as a means for lowering drug prices, and the agency has approved record numbers of generics during the past two years, addressing a major backlog that had built up before he joined the agency.
Opioid abuse reduction. The FDA has limited authority to regulate the use of opioids, but Gottlieb used every power it has to seek to reduce their use and make their use more responsible, including imposing new restrictions in the labeling of these products.
Drug prices. The FDA does not have the authority to set drug prices. But Gottlieb did seek to educate the public about how drug prices are affected by the marketplace and he directed the approval of more generics, with a focus on those that could lead to lower drug prices.
Food safety. While food safety is essential for every American, it is not as high-profile an issue as the drug issues the FDA deals with. Yet Gottlieb initiated several new polices to seek to provide further assurances that foods are safer than ever.
Changes to the device approval process. Gottlieb modernized the device approval process, changing the kinds of devices that must go through certain regulatory reviews. This is not a high-profile issue, but it is important to the future of device innovation.
What will happen to the policy initiatives and lower-profile matters that Gottlieb elevated to public attention and which have become associated with him personally?
The answer is clear to anyone who knows how the FDA functions: These policy initiatives will continue as before under new leadership.
As a former associate commissioner at the FDA, here are two reasons why I say that:
At the FDA, as at any large institution, no single person is or can be solely responsible for developing and implementing broad policy initiatives. The FDA is a collaborative environment. Initiatives such as the ones Gottlieb has become publicly associated with are very much FDA policies. They are supported with enthusiasm by the staff and are consistent with the FDA’s public health mission. Gottlieb’s departure removes a public voice for some of these policies, but not their vigorous implementation.
These initiatives are also priorities of Health and Human Services Secretary Alex Azar, who oversees the FDA and has worked closely with Gottlieb on them. Azar has a full plate of non-FDA issues at HHS, but he has been involved in every one of the FDA initiatives under Gottlieb. He will make sure that a new commissioner follows through, perhaps not with the media flair that Gottlieb demonstrated, but with the same substantive goals. On some of these issues, such as reduction of opioid abuse and drug prices, President Trump has also spoken out. And the newly named acting FDA commissioner, Ned Sharpless, is an oncologist whose views on tobacco and drug approvals are almost certainly supportive of the initiatives.
Gottlieb will be missed. The media love his openness and frequent use of Twitter and his statements. Regulated industries love the clear direction he has provided and his efforts to assure them that the FDA encourages new products to be brought to market expeditiously. The scientific community welcomes his clear understanding of the scientific issues. And the FDA staff feels that he has been a good and knowledgeable leader whose decisions support the agency’s mission.
As Gottlieb departs, the concern that his policies will be abandoned or undermined are unfounded. The FDA staff and the leadership of HHS under Azar won’t let that happen.
Wayne L. Pines, a former associate commissioner of the FDA, is president of health care and regulatory services at APCO Worldwide. He is also the vice president of the Alliance for a Stronger FDA and author or editor of a dozen books about the FDA, advertising regulation, and crisis communications.
Gottlieb let the device industry off the hook, he failed to investigate thousands of complaints and deaths. Make a list, of everything he failed to accomplish, teen smoking increased, suicide rates increased, more cases of food poisoning, even more deaths from Fentanyl, increased deceptive health marketing, increases in pharma profits, and even less accountability and fact based policies.
Fact, Data and Statistics tell us that placing a Pharma industry insider at the FDA, led to more deaths, despair and suicide, while the pharma, insurance and peddlers of quack cures are seeing record profits. America the land of alternate facts!
Glad to see him go! What he caused and facilitated for chronic pain patients is criminal! So much suffering and suicides that have resulted due to the decrease in physicians not being able to prescribe pain meds…..shameful! Why are we still being treated like the real criminals…the street drug users and those that use prescription drugs abusively? Leave the chronic pain sufferers alone and let us have what we need just to survive and work! Taking Tramadol away and turning it into a classed narcotic is just plain stupid and irresponsible as well. Some people do not need to take real opioids and Tramadol worked just fine, but it was not expensive enough for the FDA so they demonized it so it would fit into their fake crisis being perpetrated onto responsible citizens who wouldn’t even abuse an aspirin given the chance!!
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