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.
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.
- Average Drug Label Lists 70 Side Effects
- FDA cracks down on drug maker J&J for continuing recalls, J&J Depuy President resigns amid recall turmoil and growing injury lawsuits, and new Study finds 49% failure rate for J&J’s Depuy ASR hip implant
- Abacavir Causes Increased Risk of Heart Attack
- Pregnancy Labeling Change to Antipsychotic Drugs
- FDA Issues Warning for Terbutaline Due To Risk of Serious Heart Problems and Death
- Depuy Reimbursement of Costs and Revision Surgery
- J & J Hip Recall
- December 2010 Labeling Changes
- Supreme Court to Hear Arguments on Drug Side Effects
- Abbott Laboratories Recalls Up To 359 Glucose Testing Strips
- Mylan To Pay $65M To Settle Drug Price Inflation Claims
- J&J Loses First Trial
- New Weight Loss Drug Approved
- New Drug Blasts Lymphoma
- Carfilzomib Reduced Cancer In A Third Of Patients
- Mylanta Recalled
- Epilepsy Drug Faces Approval Delay
- FDA Panel Votes On Prostate Cancer Drugs
- Proton Pump Inhibitors Linked To Fracture Risk
- Sun Pharmaceuticals Inc. Receives FDA Approval
- Vandetanib Tied To Substantial Toxicity
- Feraheme Avoids Black-Box Warning
- Biodelivery Resumes Manufacturing Onsolis
- J&J Recalls Velcade
- Xanodyne Agrees To Withdraw Propoxyphene From U.S. Market
- FDA Warning For OTC Chelation Products
- Avandia Use Varies Across U.S.
- New Breast Cancer Drug Approved
- Denture Creams Cause Serious Side Effects
- GlaxoSmithKline Promotes Drugs for Unapproved Uses
- Ex-Glaxo Lawyer Charged With Making False Statements
- Bone Drug Reduces Breast Cancer Risk
- GlaxoSmithKline Fined
- Tylenol 8 Hour Caplet Recall
- Osteoporosis Drugs Linked to Fracture
- ProAmatine Pulled From Shelves
- "Phantom" Drug Recalls
- Novartis ordered to pay $422.5 Million in fines