It’s Only Money: The FDA & Foreign Plants
1 CommentBy Ed Silverman // May 2nd, 2008 // 8:24 am
When it comes to the Heparin scandal, about the only thing anyone can seem to agree is on that the FDA needs to conduct more inspections of foreign manufacturing facilities. But how this would be accomplished - and funded - is the big question. And a congressional hearing yesterday seemed to do little to provide an answer.
A bill proposed by John Dingell, the Michigan Democrat who chairs the House Energy and Commerce Committee, would impose an annual fee for all domestic and foreign drugmakers to defray the costs. Foreign drugmakers would have to be inspected every two years like domestic manufacturers, a requirement that doesn’t exist right now.
Industry trade groups told Congress they’re willing to discuss a new user-fee system, within limits. Their issues include the size of the fees; commitments the funds will be focused on higher-risk overseas manufacturers; and assurances the system will not result in hindering the timely availability of pharmaceuticals in the US market, The Star-Ledger of New Jersey reports.
Consumers Union called the proposal “a reasonable way” to help pay for more foreign inspections, but cautioned drugmakers shouldn’t be allowed to use the fees as a way to “exert undue influence over FDA in its decision-making or other functions.”
Meanwhile, Janet Woodcock, who heads the FDA’s drug review division, backed away from earlier comments in which she seemed to acknowledge the FDA needs an extra $225 million to beef up foreign inspections. Democrats on Thursday thanked her repeatedly for that remark, which they seized on as ammunition in support of their bill. But under questioning, Woodcock refused to specify how much the FDA needs to inspect facilities properly. She was also hesitant to embrace proposed user fees for drug or device makers, The Wall Street Journal writes.
LILLI
Shame on our elected officials for allowing corruption in the medical profession. Prescribing medication starts at the primary doctor’s office. Our state and federal representatives are more concerned that doctors have to pay medical malpractice insurance, instead of demanding and supporting that the medical profession must provide quality medical accountability and responsibility to all Americans.
As long as lobbyists are influencing our state and federal government nothing will change. The people must demand truth and honesty in our government otherwise punish and discipline the guilty.