House Democrats Push A Drug Safety Bill
1 CommentBy Ed Silverman // September 21st, 2010 // 7:41 am
Four Congressional Democrats have released what is called a ‘discussion draft’ that, if adopted, would increase funding and authority for the FDA to monitor drug production - both domestically and overseas - in hopes of improving safety in the wake of the Heparin scandal and other recent episodes that questioned foreign production of meds sold in the US.
The draft requires “parity” between the amount of foreign and domestic inspections of facilities; increases the number of pre-approval inspections; prohibits the entry of drugs into the US lacking documentation of safety; requires manufacturers to ensure the safety of their supply chain, and grants FDA the authority to mandate recalls of unsafe drugs.
“We’ve learned more than a few troubling truths on the safety of some prescription medications and we’ve learned it the hard way – with tragedies,” says John Dingell, chairman emeritus of the House Energy and Commerce Committee, in a statement. The others who released the document are Henry Waxman, who now chairs of the Energy and Commerce Committee; Frank Pallone, who chairs the Subcommittee on Health, and Bart Stupak, who chairs the Subcommittee on Oversight and Investigations.
In explaining their action, the quarter pointed specifically to the 2008 controversy over tainted Heparin, which laid bare the FDA’s inability to adequately monitor foreign production of medicines. The treatment, which was sold by Baxter International, contained contaminated ingredients (see this and this). More recently, two House Republicans chastised the FDA for failing to push China harder to investigate the Heparin contamination (look here).
In his own statement, Waxman made the usual noise about working with all stakeholders. But whether anything will come of this effort is, of course, uncertain, especially with November elections coming up and if Republicans win control of the House.
LillyK
Safety Drug Bill—Same as All the Unethical Patient Safety Programs.
From U. S. House of Representatives
Science Committee
Hearing on Science and Technology Advice to Congress
Testimony of Representative Rush Holt
July 25, 2006
Mr. Chairman and members of the committee, I thank you for the opportunity
None of us in Congress have time to analyze scientific and technological advances and make
reasoned, logical determinations of their direducation, but we vote on decisions about topics on a regular basis that include technical or
scientific componentsection and impact on industry, nations, andThe Congressional Research Service does a good job of gathering the current information from a
myriad of sources and presents the issues clearly in its reports. The GAO has taken upon itself to
do some technical assessments. Some of us represent districts rich in scientific and technological
expertise, in business, academia, or national laboratories and we informally or formally draw on
the knowledge of our constituents. The National Academy of Sciences has the National
Research Council, which completes studies for the federal government including
recommendations of actions to be taken by the agency or branch of government. Some
professional societies have started to reach out to Congress, and you will hear from the American
Association for the Advancement of Science and the American Chemical Society today about
what they do for Congress as far as technical or scientific advice or assessments.
We do not suffer from a lack of information here on Capitol Hill, but from a lack of ability to
glean the knowledge and to gauge the validity, credibility, and usefulness of the large amounts of
information and advice received on a daily basis. Although we would like to believe that the
scientific and technical advice and assessment provided from outside remains politically neutral,
this is not necessarily the case. In general, groups tend to be slow in responding to real-time
needs of Members of Congress or their staffers in terms of science and technology assessment or
advice, they often do not know what is happening in the halls of Congress, and have their own
agendas.
There are real gaps in what Congress gets.
We are