Category: Kevin Outterson
Budget Victim: Inspections For Compounding Pharmacies. Really?
WBUR “CommonHealth”
Kevin Outterson, School of Law
Remember all that outrage last year when we learned that a Framingham compounding pharmacy, the New England Compounding Center, was at the heart of national meningitis outbreak?…
Expert quote:
“Fungal meningitis from improperly compounded products killed 55 people and infected more that 600.”
Woburn drug maker may stop making sterile injections
Boston Globe (subscription required)
Kevin Outterson, School of Law
The owner of a Woburn specialty pharmacy that recalled two dozen drugs after the discovery of unidentified contaminants told regulators Tuesday that he was uncertain whether he would continue mixing sterile injectable medications and eye solutions, the riskiest kind of compounded drugs…
For many doctors, drug-company work a windfall
Lowell Sun
Kevin Outterson, School of Law
Dr. Andrew G. Kowal, an anesthesiologist at Lahey Hospital and Medical Center in Burlington, has earned $337,651 from Pfizer and Eli Lilly for speaking, consulting, meals and travel fees from 2009 to 2011…
Expert quote:
“We want the doctors to be making choices entirely based on medical evidence, knowing us and talking to patients. The idea they may be influenced by this type of funding is quite disturbing.”
Massachusetts Plans Stricter Control of Compounding Pharmacies
New York Times
Kevin Outterson, School of Law
New laws to strengthen state control of compounding pharmacies were proposed on Friday by Gov. Deval Patrick, in hopes of preventing another public health disaster like the current outbreak of meningitis caused by a contaminated drug made in Massachusetts…
Fungal meningitis caused 37 needless deaths
United Press International
Kevin Outterson, School of Law
The widow of the first patient who died from fungal meningitis due to contaminated steroid injections told a Washington hearing her nightmare will never end…
Elections Have Consequences: Fungal Meningitis and Compounding Pharmacies
Scientific American
Kevin Outterson, School of Law
32 deaths. 461 cases…and counting…
Friends in Congress Have Helped Drug Compounders Avoid Tighter Rules
New York Times
Kevin Outterson, School of Law
Despite two decades of dire health warnings and threats of federal intervention, the specialty drugmakers at the center of the nation’s deadly meningitis outbreak have repeatedly staved off tougher federal oversight with the help of powerful allies in Congress…
Regulating Compounding Pharmacies after NECC
New England Journal of Medicine
By Kevin Outterson, School of Law
Food and Drug Administration (FDA) rules are often forged in crisis…
Stronger FDA oversight may have averted meningitis outbreak: NEJM
Los Angeles Times
Kevin Outterson, School of Law
So far, 31 people have died of fungal meningitis and nearly 400 more have been sickened by contaminated steroid shots made by the New England Compounding Center in Framingham, Mass…
Analysis: U.S. foreign bribery penalties for drugmakers may lack bite
Reuters
Kevin Outterson, School of Law
Global drugmakers are paying tens of millions of dollars to settle U.S. allegations that they bribed their way across emerging markets, but harsher penalties may be needed to deter the practice in untapped regions where billions are at stake…
