State of the Pharmaceutical Industry
The pharmaceutical industry has really kind of taken it on the chin recently. There have been quite a few problems and other issues recently none of which have been positive. Here’s a list of ones I’m aware of.
- Baycol: Philadelphia Court OKs Baycol Settlement: Financial News - Yahoo! Finance
- Vioxx: Anti-Inflammatory Drugs Full Coverage on Yahoo! News
- FDA commissioner indicted: Ex-FDA chief faces criminal inquiry - Crime & Punishment - MSNBC.com
- Plan B Fiasco: Decision Process to Deny Initial Application for Over-the-Counter Marketing of the Emergency Contraceptive Drug Plan B Was Unusual
- Lack of Biogeneric guidance: PharmaGossip: FDA - federal judge orders action on Omnitrope
- Institute of Medicine to report on the FDA: http://www.windhover.com/ezine/pdf/DrugSafety0604.pdf
- Problems with the sleeping pill Ambien: ScienceDaily: Doctors wake up to sleeping pill risks
- Ketek antibiotic problems for Sanofi-aventis: ScienceDaily: Validity of key clinical trial questioned and US lawmakers question FDA OK of Sanofi antibiotic - Yahoo! News
- BMS antibiotic Tequin: Drug Company Taking Tequin Off Market
- FTC to subpeona drug companies for paying to keep generics off the market: Generic Drug Payoff Draws Gov’t. Interest and Drug pacts keep some generics off market - FTC - Yahoo! News
- Pfizer class action lawsuit regarding Lipitor: Class-Action Lawsuit Challenges Pfizer’s DTC Ad Claim of Lipitor’s Effectiveness in Reducing Cholesterol Levels
- DTC Drug Ads Under Fire
- UK fraud charges for price fixing: Drug chiefs on price-fixing charges - Health - Times Online
- Public Citizen | Congress Watch | Legislation Closing Loopholes in Drug Patent Law Will Help Assure Consumers Access to Lower-Priced Generic Drugs
Drug Safety in General
- FDA Is Criticized Over Drugs’ Safety Problems
- USATODAY.com - We’re curing ourselves:
- USATODAY.com - FDA ill on tracking pills:
Then there are several lawsuits of one company suing another such as Ariad vs Eli Lilly and now Ariad vs Amgen (and I’m sure there are others I’m overlooking). While I know the importance of protecting intellectual property rights to Joe Citizen on the street it just look like greedy companies suing each other to try and get rich.
There have been a couple of positive things recently. The voluntary holding off of direct-to-consumer advertising may be increasing consumer. Opinion: It’s All Relative - PhRMA’s new voluntary guidelines are about much more than DTC advertising—and they’re not really voluntary. - PharmExec
Another positive has been making public clinical trials results. Clinicaltrials2005.pdf
Now neither of these were done without some arm twisting so they don’t do much to improve consumer confidence, but they are steps in the right direction. I always believe in doing the right thing, for the right reason, in the right way (this includes at the right time), and if any of those three are missing, there will be problems.
Technorati Tags: biogenerics, FDA
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May 25th, 2006 at 2:37 pm
[…] If you want to see why that may be the case, read my post on State of the Pharmaceutical Industry. […]
June 2nd, 2006 at 4:30 pm
[…] Although I’ve not directly mentioned the Sanofi antibiotic Ketek (telithromycin), I did mention it in my post State of the Pharmaceutical Industry. Back on May 01, 2006, some in Congress raised concerns about it due to liver toxicity. It is interesting to note that the FDA turned down the new drug application not once, but twice (in 2001 and 2003) before approving it, ironically on April 1st, 2004. There are also questions surrounding one of the clinical trials and one doctor in Alabama pleaded guilty of fraud and served time in jail. […]