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Kamp Commentary: Pricing Issues Take Center Stage in D.C.

May 23, 2017 — By Coalition for Healthcare Communication Executive Director John Kamp Participants at last week’s Coalition for Healthcare ... read more

Califf Calls for Off-label Promotion Code of Ethics

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March 31, 2017 – With Congress in a seemingly permanent state of gridlock, individual states are taking actions that may ... read more

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Gottlieb Vote Headed to Full Senate

May 1, 2017 – Having cleared the Senate Committee on Health, Education, Labor and Pensions (HELP) with a 14-9 vote on April 27, Dr. Scott Gottlieb’s nomination to be the next FDA commissioner is now headed for a full Senate vote. So far, Gottlieb’s nomination has moved quickly and smoothly through the nomination process.

“Gottlieb is a great choice because of his extensive knowledge of both the FDA and the industry,” said Coalition for Healthcare Communication Executive Director John Kamp. “With two assignments at FDA and one at HHS, Scott learned the lore and the inner workings of the agency, and established a reputation with career staff as a leader. On the industry side, he’s worked with numerous small and large companies to learn to stimulate and manage innovation. He understands the difficulties of creating new products, getting them approved at the FDA and having them accepted in the market.”

Although Sen. Patty Murray (D-Wash.) expressed some concerns at the HELP committee hearing about Gottlieb’s ties to industry, Kamp noted that “industry will find him to be a tough regulator who keeps patients and the public health as his highest priorities.”

Two Democratic senators – Sen. Sheldon Whitehouse (R.I.) and Sen. Michael Bennet (Colo.) – joined their Republican fellow committee members in voting for Gottlieb’s nomination to continue on to the full Senate. According to Stat, several senators, including Murray and Sen. Elizabeth Warren (D-Mass.), asked Gottlieb to submit written responses prior to the committee hearing regarding how he would deal with possible reduced funding and staffing levels at the agency.

Industry largely is in favor of Gottlieb’s nomination – he is a medical professional and someone with a great working knowledge of and experience at the FDA. Kamp stated that when it comes to the two most important issues for marketing professionals and their clients – approvals and marketing policy – Gottlieb is supportive of industry’s point of view.

“Gottlieb will work hand in hand with Janet Woodcock to ensure that drugs are approved only when safe and effective, but also at the highest rate possible,” Kamp said. “He has already written about ways to improve the approval policies, especially for new categories where there are unmet needs. I think industry also can expect faster approvals for generic, biosimilar and combination products.”

On the marketing side, Kamp noted that Gottlieb can be expected to speed the development of policies that enable sponsors to communicate scientifically sound off-label information to health professionals. Further, “he will likely encourage the Office of Prescription Drug Promotion to speed up marketing material review times and enable more intense use of new media,” according to Kamp.

The date for a full Senate vote on Gottlieb’s nomination has not yet been set.