Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 10 May 2012 | By Alexander Gaffney, RAC
The House Energy and Commerce Committee advanced the Food and Drug Administration (FDA) Reform Act of 2012, a package of proposals to both fund and reform the agency, by a unanimous vote involving 46 members of the House of Representatives.
"The legislation ensures continuation of various FDA programs, including the Prescription Drug User Fee Act and Medical Device User Fee Act, and authorizes new user fee programs, the Generic Drug User Fee Act and Biosimilars User Fee Act, to facilitate the review and approval of life-saving and life-improving drugs and medical devices," wrote the committee in a joint statement.
"As part of the agreement, FDA will commit to certain performance goals, fostering more interaction, predictability, and certainty between industry and FDA," the committee explained. "The legislation also includes reforms to ensure patients receive quality care and timely access to new therapies while promoting innovation and job creation."
The bill has advanced through the House without acrimony despite previous indications the legislation could get bogged down with add-ons and provisions to make reforms to FDA.
Politico reported Republican members of the House may be trying to appease the pharmaceutical trade group Pharmaceutical Research and Manufacturers of America (PhRMA)-a group well known for its high-profile support of the Patient Protection and Affordable Care Act (PPACA)-in order to win back favor with the group.
The report indicates the actions of PhRMA to protect the sector have secured a far better outcome for the pharmaceutical sector than other industries, including hospital groups, have received after supporting the PPACA.
"Though few lawmakers or longtime Washington observers are willing to talk on the record about an industry that is fiercely protective of its image, most agree: The Pharmaceutical Research and Manufacturers of America is playing the Washington game as well as it ever has - and much better than other health care sectors," wrote Politico.
The progress is surprising given PhRMA's vocal support for the PPACA during its passage, its continued support of the PPACAafter its passage and GOP efforts to investigate PhRMA's negotiations with the White House.
"Health lobbyists say that Republican lawmakers still seethe at drug makers behind closed doors, and the House Energy and Commerce Committee has been pursuing a probe of the agreement with the administration to back health reform in exchange for limiting PhRMA's share of the tab to $80 billion."
Despite the potential for retribution in the GOP-controlled House, PhRMA's political strategy has reportedly focused on separating the passage of the FDA Reform Act from issues related to the PPACA.
The ability to throw resources at the problem hasn't hurt either, notes Politico. "As one drug lobbyist put it, the industry 'has the resources to get right with people once they've pissed them off.'"
The Center for Responsible Politics recently reported PhRMA was the top lobbying entity in the pharmaceutical industry, spending $5.3 million in the first quarter of 2012, with the pharmaceutical industry as a whole spending $48.1 million.
Beyond money, the deal seems to align at the rare intersection between Republican and Democratic goals, concludes Politico. Republicans get a more responsive agency with additional resources that don't require public funds, while Democrats protect the agency and their progress made in the healthcare reform deal.
"[P]erhaps the biggest factor shielding PhRMA's interests is that they line up so well with Republican free-market gospel that lawmakers would never back policies that would make them feel real pain," explains Politico. "The shared interests are a major reason Republicans and drug makers are getting along so easily over the drug user fee bill."
Regulatory Focus has reached out to PhRMA for comment and will update this page accordingly.
Committee Unanimously Approves the "FDA Reform Act"
Legislative Summary of the FDA Reform Act
Politico - GOP's big drug(maker) addiction
California Healthline - House Subcommittee OKs Measure To Extend FDA User-Fee Programs
Regulatory Focus - House Committee to Vote on User Fee Bill, Aiming for Passage in July
Tags: BIPUFA, BsUFA, User Fees, Lobbying, Legislation, PhRMA, House, MDUFA, Latest News, Senate, Bill, Congress, pharmaceutical, industry, drug, GDUFA, PDUFA, medical device
Regulatory Focus newsletters
All the biggest regulatory news and happenings.