Drug Company Issues
$750 Million Dollars Felony Settlement Paid by GlaxoSmithKline for Defective Manufacturing Practices in a Glaxo Puerto Rico Plant
Breathtaking Glaxo drug company manufacturing errors exposed by whistleblower-- Paxil drug dose mixups, bacterial contamination, and cover ups by company.
"Clinical Trial Data as a Public Good" Marc Rodwin, John Abramson JAMA, September 5, 2012. "To expand public access to clinical trial data, Congress could require the FDA to disclose all CSRs [Clinical Study Reports] that drug manufacturers submit when seeking marketing approval and also could require drug firms to disclose CSRs for all clinical trials they conduct for drugs that they market in the United States. Those actions would go a long way toward making the knowledge derived from clinical trials truly a public good."
"Studying Drugs in All the Wrong People: How the costly race to enroll subjects in psychiatric research trials is harming patients and compromising treatment" By Gabriella Rosen, Scientific American, September 6, 2012
Warner-Lambert to Pay $430 Million to Resolve Criminal & Civil Health Care Liability Relating to Off-Label Promotion May 13, 2004, U.S. Department of Justice
"...Warner-Lambert’s strategic marketing plans, as well as other evidence, show that Neurontin was aggressively marketed to treat a wide array of ailments for which the drug was not approved. The company promoted Neurontin for the treatment of bipolar mental disorder, various pain disorders, Amyotrophic Lateral Sclerosis (ALS, a degenerative nerve disease commonly referred to as Lou Gehrig's Disease), attention deficit disorder, migraine, drug and alcohol withdrawal seizures, restless leg syndrome, and as a first-line monotherapy treatment for epilepsy (using Neurontin alone, rather than in addition to another drug)...." Read more here.
"Pharmacists paid by drug company for patient details" by Kate Hagan, Brisbanetimes.com.au October 19, 2011
ONE of the world's biggest drug companies has been accused of paying Australian pharmacists to promote some of its best-selling drugs, in a controversial deal that has divided the profession. Pfizer pays pharmacies a $7 ''administration fee'' for each patient signed up to so-called support programs that involve the drug company providing information directly to patients about nine of its drugs. ...Pfizer drugs with associated support programs are Lipitor, Champix [Chantix], Xalatan, Viagra, Lyrica, Pristiq, Aricept, Celebrex and Effexor XR." Read more here.
OCTOBER 18, 2011, 1:27 P.M. ET
FDA Warns Jazz Pharmaceuticals For Violating Drug Side-Effect Reporting Rules
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON (Dow Jones)--The Food and Drug Administration warned Jazz Pharmaceuticals Inc. (JAZZ) for failure to properly submit reports on serious adverse drug events.
Drug companies are required to report to FDA any reports of side-effects that might be associated with drugs sold by the company. In cases where companies receive reports of adverse events that are considered serious or unexpected, the information must be reported to FDA within 15 calendar days, and companies are required to conduct an investigation into the reports. An adverse-event report itself doesn't mean a drug caused a problem.
In a warning letter dated Oct. 11, the FDA said Jazz failed to submit 74 serious, unexpected adverse drug reports associated with the company's narcolepsy drug Xyrem during a seven-year period. Among the reports, at least 10 of them involved a patient death. Narcolepsy is a sleep disorder.
Jazz Pharmaceuticals share prices were down 7% to $39.97 in recent trading.
The warning letter stemmed from an inspection of the company's Palo Alto, Calif., headquarters that was conducted in April and May of this year.
A Jazz Pharmaceuticals spokesperson wasn't immediately available to comment on the letter. However, the letter stated that a company representative told FDA that the firm hadn't been aware of the serious, adverse event drug reports because they had been made to a specialty pharmacy that distributes Xyrem. The FDA said Jazz received a separate warning letter in 2007 for similar postmarketing adverse-drug event reporting violations. Read FDA Warning Letter to Jazz Pharmaceuticals here.