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Another lawsuit has been filed against Teva over hepatitis C infections. Teva Pharmaceutical Industries Ltd. was sued after its anesthetic propofol allegedly led some patients to develop hepatitis C. The suit includes three patients who say they were infected with the disease during routine colonoscopies.

Read more about Drug Contamination Lawsuits...

 

The New York Times recently reported that, "More than 80% of the active ingredients for drugs sold in the United States are made abroad," often in rarely inspected plants in Mexico, China, India, and other countries. According to the report, the federal government and the generic drug industry have reached an agreement, which is favored to be passed in Congress, that will lead to "routine inspections of these overseas plants." If this legislation passes, makers of prescription drugs and medications will pay $300 million annually to underwrite these inspections.

This legislation, most likely, will lead to a faster drug-approval process and decrease the amount of drug recalls due to poorly inspected ingredients. Dr. Margaret Hamburg, the FDA Commissioner, said that the proposed prescription drug deal "would represent a real breakthrough." The Wall Street Journal also appears in agreement of this legislation, although other journals, such as the QLLS Street Journal, appear more skeptical, citing the Congressional testimony by FDA's center for drug evaluation director Janet Woodcock, which conceded that the FDA lacks the adequate agency manpower for regular overseas inspections of the foreign prescription drug plants.

 

Drugs regulators are revisiting the conflict-of-interest rules that have raised the complaints of some critics who believe that the rules overly restrict who can serve on drug advisory panels. The advisory panels are made up of outside experts who consult about drug approvals and other FDA decisions. The FDA is not required to follow the advisory  panel's recommendations, but often does.

WHAT ARE FDA COMMITTEES?

There are 49 committees and panels that advise the FDA, and more than 600 members serving on the panels. Each panel deals with a certain area of expertise. The committees provide independent advice on the approvals of drugs and medical devices, and also on general drug policy matters.

WHO IS ON FDA COMMITTEES?

The panels are made up of scientific experts such as doctors and biostatisticians. The advisers must be able to analyze complex scientific data and "understand its public health significance."

The committees also have a consumer and patient representative, as well as an industry representative who can't vote, but are present for advice and inquiries.

LEGAL GUIDELINES FOR FDA PANELS

The panels are governed by the Federal Advisory Committee Act, which applies to all government agencies. The rules try to ensure that the population, as a whole, is represented. This includes women, minorities, those with disabilities, and individuals living in different geographic regions of the country.

Each potential member of the committee must provide information about financial holdings, employment, research grants and contracts, and any other potential conflicts of interest which could hinder participation. Unfortunately, critics doubt that the FDA can discover a violation of the rules if someone decides to hide a potential conflict.

WHAT ARE FDA PANEL WAIVERS

Currently, panel members with financial ties of over $50,000 to a drugmaker or a competitor are not allowed to serve on a panel for that company. Those with smaller financial ties may still advise on the drug - though the agency must justify the move in a waiver letter, which must be approved by the FDA.

Federal guidelines cap the number of waivers the agency can use. In 2010 the agency waived about 13 percent of panel applicants. This figure is expected to diminish over time.

HOW THE FDA FINDS PANELISTS

Professional societies, industry, consumer and patient advocacy groups, along with the FDA itself, can nominate panel members based on their expertise. People can also self-nominate. Nominees must go through a vetting process for conflicts of interest and scientific expertise, after which they can serve on a panel for up to four years.

REASONS FOR BEING A PANELIST

All advisory members become "Special Government Employees" and get a salary for each meeting day, as well as travel expenses and daily costs. Many panel members have stated that the salary rarely covers the hardship of frequent, possibly cross-country, trips, the lost salary at regular jobs, and the need for extensive preparation ahead of each meeting.

But there are benefits to serving on a panel besides cost.  Serving as an FDA panelist can often boost an individual's credibility and resumé, even though many members are already established experts in their field, and do it simply to have a more direct effect on medical practice.

 

In a study recently published by Lisa Croen, PhD, of Kaiser Permanente Northern California in Oakland, a possible link was revealed between autism and the use of antidepressants. Antidepressants, or SSRIs (selective serotonin reuptake inhibitors), may create abnormalities in serotonin levels and serotoninergic pathways that can lead to autism.

According to Croen, women are twice as likely to give birth to a child with autism when taking antidepressants,  compared to woment taking no antidepressants during their pregnancy (6.7% versus 3.3%; OR 2.0, 95% CI 1.2 to 3.6). Croen’s study included 298 children with an ASD and 1,507 randomly selected controls. Croen also found that a child had the greatest odds of being born autistic if the mother took an SSRI during her first trimester of pregnancy ( CI 1.5 to 7.9).

Read more about Autism and Antidepressants...

 

Avastin, a drug approved in 2008 to treat breast, lung, and kidney cancer, has been under investigation since it's early approval was revoked by the FDA last December. Avastin, designed to treat terminal cancer patients, was reported to have adverse effects that outweighed its benefits.

Numerous women have died when taking Avastin, but an equal number have reported miraculous results. Shannon Morgan, a stage 4 breast cancer patient whose cancer spread to her stomach, has been in remission for 3 years after taking Avastin. Morgan and her husband are scheduled to testify in support of the drug during the FDA's ongoing hearings which began last Tuesday.

Read more about Cancer Drug...

 
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