Conflict-of-interest restrictions needed to ensure strong FDA review, analysis suggests

June 6, 2013, George Washington University

A 2012 law that loosened conflict-of-interest restrictions for FDA advisory panels could weaken the agency's review system and could allow more drugs with safety problems to gain market approval, says a new analysis published June 7 in Science by researchers at the George Washington University School of Public Health and Health Services (SPHHS).

The 2012 removed measures put in place by an earlier law passed in 2007, according to the report by Susan F. Wood, PhD, an associate professor of at SPHHS and Jillian K. Mador, a at the GW School of Medicine & Health Sciences (SMHS). The 2007 FDA Amendments Act put caps on the number of experts with who could serve on FDA advisory panels in order to ensure an impartial review of new drugs, the authors said.

They say there is good reason to worry about the revisions in the law that now allow FDA panels to have more members who report a conflict—such as consulting fees from companies. The removal of the requirement for "caps" on advisory committee members with financial conflicts was seen as a top priority of the pharmaceutical industry during the 2012 passage of the FDA Safety and Innovation Act.

"Panels top-heavy with experts who have financial ties to industry might be more likely to dismiss or ignore scientific evidence of risks or other problems," said Wood, who is a former FDA official and the lead author on the paper. "This analysis also suggests that loosening the restrictions could lead to an appearance of conflict—and to potentially biased recommendations for approval or disapproval of a FDA regulated product."

The authors point to historical examples of cases in which loaded panels voted for drugs that were later found to have serious safety problems.

The 2012 law was passed after the drug industry complained that the conflict of interest restrictions slowed down the FDA approval process and made it hard to fill panel positions with qualified experts. But Wood and Mador looked at the evidence and concluded that there are plenty of scientists with expertise to fill these positions—without the ties to the industry.

The analysis goes on to say that the restrictions did not affect FDA's productivity in the past and there is little reason to think that reinstituting the caps would slow down the process of bringing safe new drugs to market today. The analysis also demonstrates that the caps have never been reached, so FDA had apparently been successful in identifying experts without financial conflicts.

The analysis concludes that the evidence does not support the decision to remove the caps on conflict of interest and points out that Congress will soon begin discussing reauthorization of the 2012 law which is revised every five years. The authors urge the scientific and medical community to weigh in early on those discussions in order to point out concerns—and to ensure that the Advisory Committee and review process remains strong and effective.

Wood and Mador's new analysis, "Uncapping Conflict of Interest," appears in the June 7 issue of Science.

Explore further: US experts review heart attack risk of diabetes drug

More information: "Uncapping Conflict of Interest?," by S.F. Wood et al. Science, 2013.

Related Stories

US experts review heart attack risk of diabetes drug

June 5, 2013
GlaxoSmithKline's controversial diabetes drug Avandia, restricted in the US and banned in Europe over concerns it raises heart attack risk, is getting a second look this week by US medical experts.

FDA weighs lifting safety restrictions on Avandia (Update 2)

June 3, 2013
A former blockbuster diabetes pill that was subjected to major safety restrictions in 2010 may be less risky than once thought, according to the latest analysis of the much-debated GlaxoSmithKline drug Avandia.

Judge lets challenge to FDA tobacco panel proceed

August 1, 2012
(AP) — A challenge by two of the largest U.S. cigarette makers alleging conflicts of interest in the Food and Drug Administration advisory panel's review of tobacco products can move forward, a federal judge has ruled.

FDA reviewing heart risks of Glaxo diabetes pill

April 12, 2013
(AP)—The Food and Drug Administration will hold a meeting in June to reassess the safety of GlaxoSmithKline's former blockbuster diabetes drug Avandia.

Tobacco companies are not public health stakeholders

May 28, 2013
When assessing information presented by the tobacco industry, the US regulator, the Food and Drug Administration (FDA) and regulatory bodies in other countries, should be aware that they are dealing with companies with a ...

FDA warns consumers of dangers of the stimulant DMAA

April 15, 2013
(HealthDay)—The U.S. Food and Drug Administration is attempting to halt distribution of dietary supplements that contain the stimulant dimethylamylamine (DMAA), following reports of illness and death associated with these ...

Recommended for you

In most surgery patients, length of opioid prescription, number of refills spell highest risk for misuse

January 17, 2018
The possible link between physicians' opioid prescription patterns and subsequent abuse has occupied the attention of a nation in the throes of an opioid crisis looking for ways to stem what experts have dubbed an epidemic. ...

Patients receive most opioids at the doctor's office, not the ER

January 16, 2018
Around the country, state legislatures and hospitals have tightened emergency room prescribing guidelines for opioids to curb the addiction epidemic, but a new USC study shows that approach diverts attention from the main ...

FDA bans use of opioid-containing cough meds by kids

January 12, 2018
(HealthDay)—Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Taking ibuprofen for long periods found to alter human testicular physiology

January 9, 2018
A team of researchers from Denmark and France has found that taking regular doses of the pain reliever ibuprofen over a long period of time can lead to a disorder in men called compensated hypogonadism. In their paper published ...

Nearly one-third of Canadians have used opioids: study

January 9, 2018
Nearly one in three Canadians (29 percent) have used "some form of opioids" in the past five years, according to data released Tuesday as widespread fentanyl overdoses continue to kill.

Growing opioid epidemic forcing more children into foster care

January 8, 2018
The opioid epidemic has become so severe it's considered a national public health emergency. Addiction to prescription painkillers, such as oxycodone and morphine, has contributed to a dramatic rise in overdose deaths and ...

4 comments

Adjust slider to filter visible comments by rank

Display comments: newest first

VendicarE
1 / 5 (2) Jun 06, 2013
Nothing but American filth and Corporate Corruption.

"The 2012 law was passed after the drug industry complained that the conflict of interest restrictions slowed down the FDA approval process and made it hard to fill panel positions with qualified experts."
UrpGag
not rated yet Jun 06, 2013
Paxil is the proximate cause of death of my eleven year old daughter in 1998 as evidenced by trial record. Furthermore, Paxil and tagamet are directly involved in my fugue while driving and getting into a fatal accident. the pharmaceutical giants are strongly motivated to hide dose related side effect profile information from our doctors by direct greed. we must keep these self serving corporations and their agents out of our regulatory bodies or more human beings must die. period. keep the corporations out of the federal regulatory agencies or we are in for far worse trouble than slow releases of medication.
aironeous
not rated yet Jun 07, 2013
This is corruption. If the capitalism abusing corrupt filth of big pharma and FDA had their way they would reclassify water as a drug because it cures dehydration so they can charge $50 a bottle. This is the filth of the earth betraying all of mankind next only to the filth that abuses capitalism on wall street and never goes to jail.
alfie_null
not rated yet Jun 09, 2013
Seems like medicine (pharmacology in particular) is one of those areas where companies are poorly motivated to provide the best value to their customers.

While I note that bringing a new drug to market is hideously expensive I also understand that pharma companies go on to spend vast amounts more, marketing their medications. To end users who can't even purchase the products, only pester their physicians for prescriptions. And in maintaining an army of representatives to pimp their products to physicians across the country. And, no doubt, to encourage legislators to be friendly to pharma.

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.