July 26, 2017
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – As an Aug. 1 deadline for potential layoffs looms, U.S. Food and Drug Administration Commissioner Scott Gottlieb told staff in an email that he intends to delay any labor reductions until the end of September unless Congress authorizes its user fee program to provide the necessary funding.
In the email, Gottlieb said he is confident Congress will pass the reauthorization of the Prescription Drug User Fee Act, as well as the fee programs for medical devices, generic drugs and biosimilars, by the end of September. Those fees are used to fund employment. If the reauthorization is not passed, the FDA has indicated it could begin laying off thousands of employees.
Gottlieb said the FDA Reauthorization Act (FDARA) was “overwhelmingly” passed by the U.S. House of Representatives earlier this month, but has yet to be discussed in the Senate. Gottlieb said he believes the Senate will soon take up the act, particularly since the legislative body delayed its August recess.
“We hope that the Senate will use this additional time to make progress towards reauthorizing the User Fee programs. I know that the Members of Congress working on the reauthorization of these User Fee programs understand how critically important it is to pass FDARA before September 30, so that the FDA can continue, without disruption, our vital work on medical products for patients as we fulfill our mission to protect and promote the public health,” Gottlieb said in his email.
However, Gottlieb noted that if Congress does not approve FDARA, the regulatory agency could begin layoff notices that would disrupt its services.
After the House approved FDARA, Jim Greenwood, president and chief executive officer of BIO (Biotechnology Innovation Organization) hailed the vote as “an important victory for patients and for the next generation of medical innovation.” Earlier this week, a spokesperson for BIO told Focus, the publication of the Regulatory Affairs Professionals Society that the organization was encouraged by Gottlieb’s email to staff. The BIO spokesperson added that federal lawmakers “are very aware of the dire consequences of not reauthorizing these crucial programs by the end of the current fiscal year.”
If the FDA is forced to begin layoffs, which would stymie Gottlieb’s plans to focus on recruiting top talent to fill a number of vacancies at the agency. In a blog post earlier this month, Gottlieb said he was evaluating hiring practices at the FDA in order to compete with private employers. IN the blog post Gottlieb said the FDA’s first order of business when it comes to hiring will be to fill positions that will support its PDUFA commitments. Gottlieb said too many of those positions are vacant and the backlog of those applications is “substantial.”
All while Gottlieb is looking to hire staff though, he has to assure his current employees he is looking out for them as well – which is what the goal of his email was.
“I consider myself very fortunate to have the opportunity to work with such a talented and dedicated workforce in pursuit of a worthy mission. I know that a perception of uncertainty related to FDARA can be disruptive to you professionally and personally. I promise that this is a very high priority of mine. I am personally dedicated to making sure we have the resources we need to continue our work without disruption. I will work diligently, alongside you, to support a timely reauthorization of the User Fee programs,” Gottlieb said in the email.
