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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

May 18, 2017 – At this week’s information-packed Coalition for Healthcare Communication’s Rising Leaders Conference, keynote speaker and former FDA ... read more

The Marketing Implications of Tax Reform

By John Kamp, Coalition for Healthcare Communication Executive Director May 11, 2017 – Although no one seems to like the ... read more

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 ... read more

What Medical Marketers Can Expect from President Trump, Republican-led Congress

April 24, 2017 – There is no doubt that the Trump administration is likely to change health policy, but the ... read more

Kamp: Three Ways Congress Could Suppress DTC or All Medical Marketing

Coalition Commentary by Executive Director John Kamp April 17, 2017 — Agencies, media and clients all need to watch closely ... read more

States Make Moves to Ease, Restrict Medical Communications

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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FDA Appears Subject to Some Exemptions from Hiring Freeze

Feb. 13, 2017 – A memo sent to Department of Health and Human Services (HHS) division heads last week from HHS Acting Deputy Secretary Colleen Barros attempts to better define exemptions from the federal hiring freeze imposed by President Donald Trump on Jan. 23, and may provide some relief to the FDA, which has hundreds of job vacancies.

According to the memo, “a number of position types have been identified as meeting … exemptions from the hiring freeze.” Those specified in the memo include positions that “are deemed necessary to meet national security or public safety responsibilities.”

Under the “Patient Care and Health-related Research” category, the memo specifies that critical positions include “scientific, research, and program-related position that oversee clinical and/or public health programs”; under the “Public Health Safety and Emergencies” category, the memo states that positions that involve preparing for and responding to public health emergencies, such as pandemic influenza, Ebola and the Zika outbreak, are exempt, as are positions that ensure “public health safety through programs such as food, drug and medical device safety” and that respond to national public health emergencies, such as the opioid epidemic.

FDA advisory board members appear to fall under an additional, limited exemption, which states that during the 90-day period that the initial executive order is in place, “appointments will only be considered for those committees that are legally mandated, but not for those that are discretionary.”

The Barros memo follows a Jan. 31 memo from the Office of Management and Budget (OMB) and the Office of Personnel Management which states that exemptions from the hiring freeze are permitted for “filling of positions under programs where limiting the hiring of personnel would conflict with applicable law.” Many have argued that FDA new drug review activities would be included under that exemption.

Indeed, Regulatory Focus reports that Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.) sent a letter to OMB last week asking that it clarify how the freeze specifically impacts the FDA and its ability to implement the 21st Century Cures Act.

“FDA’s ability to carry out numerous new responsibilities under Cures – such as antibiotic approvals, validation of drug development tools, patient focused drug development, and issuance of new guidance – will depend on the agency’s ability to staff up,” the Upton/DeGette letter stated. The lawmakers also asserted in the letter that FDA user fee funds should be made available for hiring.