MALPRACTICE PAYOUTS HAVE NOT SOARED, REPORTS SAY
June 2, 2005 08:07

There may be a medical malpractice crisis, but studiesreleased suggested that jackpot jury awards were not the cause. Many doctors blame such judgments for skyrocketing insurance premiums. But the average malpractice claim payout rose about 4% a year from 1991... (Read Article)

Drug companies that are granted accelerated approval by FDA for some treatments complete less than half of post-market clinical trials promised as a condition of approval, according to a congressional report commissioned by Rep. Edward Markey (D-Mass.) and released Wednesday, the... Los Angeles Times reports. Since 1992, FDA has granted pharmaceutical companies accelerated approval following an abbreviated series of clinical trials if a medication appears promising in the treatment of a life-threatening illness. The companies must agree to conduct more complete studies gauging safety, efficacy and side effects after the drug is sold. Accelerated approval drugs are not required to include any additional warnings (Alonso-Zaldivar, Los Angeles Times, 6/1). For the report, Markey staff members examined FDA and Securities and Exchange Commission data on 91 studies ordered for 42 products approved from 1993 to October 2004. Of the 91 studies ordered, 46 studies have been completed, 42 have not and three have been delayed, according to the review. Half of the uncompleted studies have not yet begun. The report also found that 68% of drug companies did not disclose to SEC that they were required to conduct additional studies. According to the Dow Jones/Wall Street Journal, "It is unclear if companies were required to divulge that information." http://www.medicalnewstoday.com/medicalnews.php?newsid=25522

Date: Wed, 1 Jun 2005 10:11:59 -0400
From: CDER MEDWATCH LISTSERV
Subject: FDA MedWatch - Able Laboratories Recall of all Manufactured Drugs

MedWatch - The FDA Safety Information and Adverse Event Reporting Program:

The Food and Drug Administration notified consumers and healthcare professionals of a nationwide recall of all manufactured drugs (mostly generic prescription drugs, including drugs containing acetaminophen) from Able Laboratories of Cranbury, NJ, because of serious concerns that they were not produced according to quality assurance standards. Able Laboratories has ceased all current production.

FDA recommends that people who have been taking drugs produced by this firm speak with their health care provider or pharmacist to obtain a replacement drug product. Consumers should continue taking the medication until they have spoken with their health care provider. FDA has provided a list with the names of the recalled drugs and their imprint codes, marks (usually letters and numbers) found on the surfaces of drugs.

Read the 2005 safety summary, including a link to the FDA News Release, at: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01182.html