The U.S. Senate health committee on Wednesday met with the longtime Philadelphia doctor whom President Donald Trump has nominated to head the Food and Drug Administration — Stephen Hahn, a graduate of Temple’s medical school, former head of the Penn medical school’s radiation oncology department (2005-14), and a familiar figure at its University City campus from 1996 until he headed to Texas to be chief medical executive for the MD Anderson Cancer Center five years ago.
Penn Medicine chief executive Kevin B. Mahoney offered “enthusiastic” support to Hahn’s nomination in letters last week to Pennsylvania Sens. Pat Toomey and Bob Casey. He called Hahn, who, if approved, will preside over the agency that will rule on gene therapy and drug approvals for a proliferation of Penn-backed start-up companies, “a generous colleague, exemplary practitioner and educator” committed “to clinical care, advancing training and research, and patient care."
In his prepared statement to Congress, Hahn pledged to uphold the FDA’s mission balancing drug development, food safety, and public health. But much of the hearing was taken up by “the topic of e-cigarettes and vaping [and] vaping-related illnesses,” noted Christopher P. Molineaux, president of Life Sciences PA, which represents area drug developers.
“The explosion of vaping as an issue has seemed to relegate all other issues to secondary importance,” added Michael Carrier, a Rutgers Law School professor and antitrust scholar who has testified in Congress on drug pricing.
Molineaux said senators also quizzed Hahn on “drug importation, drug shortages, generic and biosimilar competition, and ensuring the FDA is ready to quickly and effectively review all of the medicines coming to market,” including new cell and gene therapies, many of which are targeted to so-called orphan diseases affecting relatively small groups of people, where potential profit margins are high.
Hahn in his testimony stressed his concern with high prescription-drug prices and agreed that Americans want “urgent” action — but did not provide a plan for that action, Carrier noted. He said he hopes Hahn follows predecessor Scott Gottlieb in pressing drugmakers to produce more generic drug samples, oppose drug company attempts to file “frivolous” complaints designed to slow competition, and take other steps to “show he’s serious about lowering drug prices.”
The committee plans a vote on whether to recommend Hahn to the full Senate on Dec. 3.
It wasn’t Hahn’s first appearance in Congress. Ten years ago he was called on by the House Veterans’ Affairs oversight and investigations subcommittee to explain what its then-chairman, Rep. Harry Mitchell (D., Ariz.), called a “lack of quality and standard controls” and “egregious errors” in a troubled prostate radiation implant (brachytherapy) program staffed by doctors from Hahn’s Penn department under contract to the next-door Philadelphia Veterans Administration Medical Center.
Some veterans suffering from prostate disease were subject to improper and ineffective treatments, resulting in damage to healthy tissue and failure to properly target cancers. The problems “went undetected for almost six years, until reported by VA staff,” Mitchell said at the time in a statement.
The damage “could have been prevented” with proper oversight, said Bob Filner (D., Calif.), the House veterans’ affairs committee chair, in a statement at the time. Five patients later sued Penn. The school didn’t reply to questions on the resolution of those cases.
In his 2009 testimony, Hahn apologized to veterans and their families that the patients “did not in every instance receive the best possible care.” He added that the procedure was difficult and that physician Gary Kao had agreed on Hahn’s request to stop using the therapy in treating patients; Kao was later barred from performing nuclear medicine by the Nuclear Regulatory Commission, which fined the VA center $227,000 for the problems at the by-then defunct brachytherapy program in 2010.
Kao now has a lab at Penn that studies cancer biology. Hahn and Kao continued to collaborate in their research work, coauthoring several scholarly papers, including one published last year.