FDA Policy/General

Senator Burr Introduces 'Clean' Version of User Fee Bill

Senator Richard Burr (R-NC) has introduced a watered-down FDA user fee reauthorization bill that is intended to address Republican concerns over the current user fee package that the Health, Education, Labor and Pensions (HELP) Committee marked up last month. HELP committee ranking member Burr said the new measure is a cleaner version of the earlier bill and removes a “partisan reconciliation package that includes devastating drug pricing proposals” that Senate Democrats added.

The clock is ticking and legislators are stepping up pressure to pass reauthorization before FDA has to begin issuing furlough notices next month. On 7/14, the House Energy and Commerce Committee leadership urged the Senate to “urgently” reauthorize FDA’s user fee programs. “Unless the Senate acts urgently to meet its deadline, FDA will be forced to issue reduction-in-force notices and furlough thousands of workers who ensure the safety and efficacy of medical products,” committee chairman Frank Pallone, Jr. (D-NJ) and ranking member Cathy McMorris Rodgers (R-WA) said in a statement (see earlier story).

“Unfortunately, the user fee package reported out of (HELP) Committee would, if enacted, undermine the very purpose of the user fee program,” Burr said in a release. “The policies added to this bill endanger the development of drugs for rare diseases, imperil intellectual property rights, threaten Americans’ access to breakthrough treatments and cures, and deter private sector innovation. In effect, this proposal would compromise the FDA’s overall ability to keep pace with advancements in the industry it regulates. And Democrats’ recently released drug pricing proposal would further reduce private sector investment, making it more difficult for Americans’ to access new, lifesaving medicines.”

Burr explained that his legislation “preserves the user fee agreements as they’ve already been negotiated – without harmful additions… ” As the authorizing deadline approaches, this clean reauthorization represents the clearest path forward.” Without reauthorization, the user fee program would expire 9/30.

To read the legislative text of Burr’s Food and Drug Administration Simple Reauthorization Act, click here.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome