This Idea Has Been Circulating Since The 2005 Grassley-Dodd Bill, With No Real Movement Forward In Past Five Years
(Posted by Tom Lamb at DrugInjuryWatch.com)
Five years ago, on April 28, 2005, in the very first article posted to this Drug Injury Watch blog, I wrote about the so-called Grassley-Dodd bill which, in part, would move the FDA's drug-safety office out of the agency's branch:
Senator Chuck Grassley (R., Iowa) and Senator Christopher Dodd (D., Conn.) are co-sponsoring a bill....
... the Grassley-Dodd bill would move the FDA's drug-safety office out of the agency's branch which is responsible, initially, for evaluating and deciding whether to allow new prescription drugs to be sold for use by patients in the United States. This proposed legislation would create a new center for post-market review of approved drugs, and put the drug-safety office over there, giving this FDA department increased independence.
Ironically, exactly five years later, on April 28, 2010, Senator Grassley testified at a House Subcommittee hearing chaired by Representative Rosa DeLauro (D., Conn.) and he described the continuing need for a legislative reform to empower the office that monitors post-market drug safety at the FDA.
During Senator Grassley's April 2010 Congressional testimony about the current FDA structure:
There’s a lack of equality between the FDA office that decides whether to approve a drug, or not, and the FDA office that monitors a drug’s safety once a drug is on the market and being sold to patients, when much more information is available than can ever be achieved from pre-market samples.
Grassley went on to state that the result is some FDA physicians and scientists who are committed to post-market monitoring of drugs have sometimes been suppressed and even ignored.
In her April 28, 2010 piece, "Critics cite Avandia in pushing FDA safety reforms", Reuters reporter Lisa Richwine provided us the reactions of the FDA and Representative DeLauro to the this testimony by Senator Grassley in the context of the current debate about the safety of the diabetes drug Avandia:
Two drug safety reviewers have recommended that [GlaxoSmithKline Plc diabetes drug Avandia] come off the market after concluding it was more dangerous to the heart than rival drug Actos by Takeda Pharmaceutical Co Ltd.
That has prompted new calls for more independence and power for the reviewers who analyze a drug's risks after it reaches the market, an idea circulating for years. Critics say more authority lies with the staff who approve drugs and are therefore reluctant to withdraw a medicine they supported.
The FDA has said it is undertaking an internal review of drug safety decision-making in addition to bringing Avandia to an advisory panel of outside experts in July. "This review will make recommendations regarding the agency's approach to safety issues including Avandia," FDA spokeswoman Karen Riley said on Wednesday.
A panel that met in 2007 heard from a safety reviewer who felt the drug should no longer be sold. That panel voted 22-1 that Avandia was safe enough to stay on the market.
Representative Rosa DeLauro, the subcommittee's chairwoman, said the "evidence suggests that we should look into strengthening either the independence or the powers of the FDA's drug safety office so that its recommendations no longer go unheeded."
DeLauro said she wanted to provide input to the FDA ahead of the July advisory panel meeting. She also said she might pursue FDA safety reforms when her panel is setting funding levels for the agency.
"We would like to address some of these issues," she said.
Going back to April 2005, I concluded my first Drug Injury Watch blog post by stating:
We will keep you posted on the status of this [Grassley-Dodd] bill; and, when the time comes, you should urge your representatives in Washington to support this legislation.
Unfortunately, a full five years later, I am sad to report, now, that not much has changed since 2005 with respect to the FDA hierarchy when it comes to drug-safety issues that emerge only after a drug like Avandia has been approved by the FDA.
Of course, as always, we welcome all opinions and perspectives on this topic. For that purpose, you can submit your Comment, below.
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