FDA Says Drug Maker Altered Data on Pills
Posted on: Tuesday, 12 July 2005, 18:01 CDT
CRANBURY, N.J. - Able Laboratories Inc., a maker of generic drugs that recalled all of its products in May, gave the government fabricated data so its drugs would appear to meet federal standards when they did not, according a Food and Drug Administration report.
An FDA report made public this week cited 41 instances dating to 2001 in which drugs were found to have too much or too little of their active ingredients in the Cranbury-based company's tests. But in each case, the drugs' strength was reported to be within legal limits.
The report, based on a two-month inspection of the company's facilities and records, also cited nine instances when the company failed to issue alerts about impure drugs.
The FDA's report, dated July 6, details the internal control problems that led to the resignation of two chief operating officers and have left the company in shambles.
In May, the firm voluntarily recalled all its drugs, explaining that an internal probe found problems with testing procedures for some drugs. Before that, Able manufactured more than 40 generic versions of name-brand drugs used to treat pain, inflammation, obesity, cardiovascular conditions and neurological ailments.
The company was a favorite of investors until the recall, which sent the stock plummeting from a 52-week high of $26.49 on May 19. On Tuesday, the stock fell 6 cents to close at $1.42 on the Nasdaq Stock Market.
On Friday, Able announced it was considering filing for bankruptcy protection. The company is also seeking the a consent decree that would allow it to operate under federal court supervision.
The company said in a July 8 letter to the FDA that it will not respond formally to the agency's inspection report because it has asked for a consent degree. "This intent, however, should not be interpreted that the company admits to any violation of law or regulations," read the letter, which was signed by Gary Boehm, Able's chief scientific officer.
Company officials did not respond to a telephone message or an e-mail from The Associated Press on Tuesday.
Source: Associated Press/AP Online
Related Articles
- Ore Pharmaceuticals Files Investigational New Drug Application With FDA
- Sciele Pharma Submits Supplemental New Drug Application to FDA for New Sular Formulation
- DOR BioPharma Files New Drug Application With FDA to Market orBec for GI GVHD
- Almost All New Drug Approvals Receive FDA Requests for Post-Marketing Studies
- Genta Files New Drug Application for FDA Approval of Genasense(R) Plus Chemotherapy for Patients With Advanced or Refractory Chronic Lymphocytic Leukemia
- Osiris Receives Orphan Drug Status From FDA for Lead Stem Cell Drug
- Spectrum Pharmaceuticals Announces Filing of an ANDA for an Injectable Anticancer Drug With the FDA
- Bothell-Based Natural Remedy Company Receives Investigational New Drug Number From FDA
- Biogen Calls Halt to Its Multiple Sclerosis Drug Trial; Stock Plummets
- Illegal Online Sales of Prescription Drugs Pose Threat, FDA Official Says
 |
 |
User Comments (0)
RSS Feeds