Regulatory Focus™ > News Articles > With NDA on the Line, Company Hires Former FDA Commissioner to Head up Regulatory Team

With NDA on the Line, Company Hires Former FDA Commissioner to Head up Regulatory Team

Posted 12 September 2013 | By Alexander Gaffney, RAC

With a new drug approval decision on the line, one struggling company's regulatory affairs team is about to get a new employee with an impressive formal title: commissioner of the US Food and Drug Administration (FDA).


The company in question is Braeburn Pharmaceuticals, a New Jersey-based pharmaceutical company involved in development therapies to treat addiction, which said in a statement that it had hired Frank E. Young as executive vice president of clinical and regulatory affairs.

Young most notably served as commissioner of FDA under presidents Ronald Reagan and George H.W. Bush from 1984 through the end of 1989, overseeing the creation of the 505(j) generic drug pathway under the Hatch-Waxman Act of 1984, the passage of the Prescription Drug Marketing Act of 1987 and the early and tumultuous years of the AIDS crisis.

After his tenure as commissioner of FDA, Young became assistant secretary for health, science and the environment at the US Department of Health and Human Services, and later as director of the Office of Emergency Preparedness. Young retired from public service in 1996, but in 2002 joined Essex Woodlands Health Ventures, and has also served as a scientific and regulatory advisor for various companies since then.

The Situation at Hand

Young joins Braeburn during a tumultuous time for the company. In April 2013 the company announced that its main development partner, Titan Pharmaceuticals, had received a complete response letter from FDA for its new drug application (NDA) for Probuphine, a subdermal implant for treating opioid dependence in adult patients.

"Titan and our partner, Braeburn Pharmaceuticals, are extremely surprised and disappointed with the FDA's response," Titan wrote at the time of FDA's CRL.

"We believe Probuphine has demonstrated both safety and efficacy in accordance with primary endpoints that were pre-agreed with the FDA and, moreover, the safety, efficacy and overall approval of Probuphine was strongly supported by the Psychopharmacologic Drugs Advisory Committee," said Marc Rubin, M.D., executive chairman of Titan Pharmaceuticals. "Given the nationally-recognized, growing and devastating opioid dependence epidemic, there is critical need for new safe and effective treatments that reduce the likelihood of abuse, diversion and accidental pediatric exposure, and Titan and Braeburn remain committed to making Probuphine available for patients that need it."

And addressing FDA's concerns and getting Probuphine approved is what Young was hired to do, according to the former commissioner.

"I am impressed with Braeburn's commitment to develop therapies to mitigate health problems associated with opioid addiction," said Dr. Young. "I look forward to working with FDA and the Braeburn team to satisfy fully FDA's concerns."

Braeburn Statement

Tags: Commissioner

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