FDA Blasts EpiPen Maker For Not Investigating Complaints About Life-Threatening Device Flaws
The FDA cites troubling incidents where the failure to properly investigate and take action over defective products had led to patient deaths.
The New York Times:
F.D.A. Accuses EpiPen Maker Of Failing To Investigate Malfunctions
The Food and Drug Administration this week accused the drugmaker Pfizer of failing to properly investigate reports of malfunctioning EpiPens, including incidents when patients died or became severely ill after the device failed to work. Pfizer manufactures the EpiPen, which treats allergic reactions, for the drugmaker Mylan. (Thomas, 9/7)
Stat:
FDA: Lapses By EpiPen Maker Tied To ‘Serious’ Problems, Patient Deaths
Throughout last year, Meridian Medical Technologies received hundreds of complaints that the EpiPen device, which is used to combat serious allergic reactions, failed to operate during life-threatening emergencies. Yet the Pfizer manufacturing unit not only failed to thoroughly investigate the problem, but did not initially remove potentially defective products. The lapses were detailed in an extraordinarily disturbing Sept. 5 warning letter the Food and Drug Administration sent to the Pfizer unit and described the findings of an inspection last March. (Silverman, 9/7)
In other pharmaceutical news —
Stat:
Alnylam Gene-Silencing Drug Studies In Hemophilia Suspended Following Patient Death
The death of a hemophilia patient due to a blood clot has forced Alnylam Pharmaceuticals (ALNY) to temporarily suspend studies of its gene-silencing drug fitusarin, the company said Thursday. The new safety setback comes at a particularly bad time for the Cambridge, Mass.-based biotech company, developers of drugs based on a technology known as RNA interference, or RNAi. In the next days to weeks, Alnylam is expecting to receive and announce results from its first phase 3 clinical trial for a different drug called patisiran in a rare nerve condition. (Feuerstein, 9/7)
Stat:
It's Not Just One Suspect Vaccine Trial: Most New Drugs Are Tested Overseas
The clinical trial for a herpes vaccine flouted just about every norm in the book: American patients were flown in to the Caribbean island of St. Kitts for experimental injections. Local authorities didn’t give permission. Nor did the Food and Drug Administration. Nor did a safety panel. That’s why the trial — run by a startup which has since received funding from billionaire investor Peter Thiel — prompted widespread alarm and censure when it was reported last week by Kaiser Health News. (Robbins, 9/8)
The Associated Press:
Prosecutors Want Shkreli’s Bail Revoked Over Clinton Posting
Federal prosecutors on Thursday filed a court motion asking a judge to revoke Martin Shkreli’s bail and throw him in jail because of recent threats the so-called “Pharma Bro” allegedly made against Hillary Clinton. “Since his conviction on August 4, 2017, Shkreli has engaged in an escalating pattern of threats and harassment that warrant his detention pending sentencing,” prosecutors wrote in their motion. (McElroy, 9/7)
Kaiser Health News:
Meningitis B Vaccine’s High Price Tag Poses A Health Care Conundrum
Four years ago, when meningitis B, an extremely rare but potentially lethal form of the infection, sickened a small number of college students at Princeton and the University of California-Santa Barbara, there was no vaccine against the disease sold in the U.S. Despite its availability abroad, it had never been licensed in the country due to its limited marketability. Scientific evidence supporting an absolute need to immunize against meningitis B still falls short. The risk of contracting it is smaller than that of being involved in a car crash. (Luthra, 9/8)
San Francisco Chronicle:
Startup That Makes Personalized Cancer Treatments Gets $93 Million In Funding
Gritstone Oncology, the 2-year-old Emeryville startup that develops immunotherapy treatments for cancer, has received $93 million in new financing, the company announced Thursday. The privately held company is one of several Bay Area startups making inroads in applying artificial intelligence to drug discovery, a fast-growing segment of the health technology field that has attracted hundreds of millions of dollars from investors over the last few years. (Ho, 9/7)
