FDA Approved New Drug Despite Ongoing Investigation of Lab Misconduct
by Charles Seife and Rob Garver, Special to ProPublica, April 22, 2013, 9:22 a.m.
Last week, ProPublica reported that the Food and Drug Administration allowed dozens of medications to stay on the market, even though the research designed to prove their safety and effectiveness was undermined by “egregious” violations at a major pharmaceutical research laboratory in Houston. New information shows that even after the FDA had cited the lab for falsifying data and other misconduct, the agency issued a brand new approval to a drug tested there.
The FDA has refused to reveal the names of any of the approximately 100 drugs affected by the fraud at the Houston lab of the firm Cetero Research, saying that to do so would reveal confidential commercial information. ProPublica was able to identify five of those drugs, and now we’ve found a sixth. This one was approved after the agency had already cited the Houston lab for misconduct.
The drug is a generic version of Tussionex, which combines a long-acting narcotic cough suppressant with an anti-allergy medication. Manufactured by TrisPharma, the drug has a tongue-twisting chemical name: hydrocodone polistirex/chlorpheniraminepolistirex.
“While We Were Sleeping”
Orwell Rolls In His Grave, featuring MCM – Buy the DVD
About News From Underground
News From Underground is a daily e-news service run by Mark Crispin Miller, a Professor of Culture and Communication at NYU. It is based on his belief that academics, like reporters, have a civic obligation to help keep the people well-informed, so that American democracy might finally work.
If you'd like to receive updates delivered to your inbox daily, sign up for News From Underground Alerts:
Help News From Underground!
Message from Mark: "I am a one-man operation, although assisted greatly by some volunteers, and, now and then, by people paid by others for one-time projects. There is no shortage of skilled, dedicated folks out there who want to help me. There is, however, nothing I can pay them with, unless you decide you can contribute something."
Please donate via the PayPal button above or via PayPal by email to: firstname.lastname@example.org
- With our voting system run by rightist gremlins, Hillary—or ANY Democrat who runs for president—is going to “lose”
- College students in the USA should look to Chile
- Run (into the ground) by Wall Street, NYU is Number #1 in student prostitution
- A captive FCC has put our health and privacy at risk
- Doctor who linked autism to vaccines apparently both shot and drowned himself
- Don’t buy these products from Koch Industries! on
- Wisconsin to buy “all new voting machines”—and Koch/Walker will go on “winning” there FOREVER! on
- Please SIGN Elizabeth Warren’s petition to halt “fast track” of TPP! on
- 2nd Amendment was devised to keep Americans in chains on
- Update on the strange death of Nancy Schaefer on
- Forbidden Bookshelf
- Don't buy these products from Koch Industries!
- With our voting system run by rightist gremlins, Hillary—or ANY Democrat who runs for president—is going to "lose"
- NY Fed moving to Chicago, Feds stocking up on ammo, NORAD hunkering down: What's up?
- Iceland got over the recession fast—by jailing the banksters, and bailing out the people
- Suburban Guerrilla
- Mainstream Baptist
- Writers Voice
- Election Defense Alliance
- Citizens for Legitimate Government
- History Unfolding
- t r u t h o u t
- Barry Gordon
- The Ostroy Report
- Talking Points Memo
- William Betz
- Words of Power
- The International Human Press
- Thom Hartmann
- Media Matters
- alias Bruce
- Veterans for Common Sense
- Democratic Undergroud
Need a bigger font size?
- Your link could be here too, contact us for pricing details.