The Burrill Report

More than two dozen people who suffered as a result of drug shortages have sued the U.S. Department of Health and Human Services, the U.S. Food and Drug Administration, and the National Institutes of Health alleging that the organizations failed to take adequate enforcement actions against drugmakers and allow for alternative means to protect supplies. “Corporations that cause drug shortages have demonstrated beyond a doubt that they cannot provide a reliable drug supply, so there is no rationale to reward them with future profits from the remaining survivors of the shortage,” said the plaintiffs’ attorney, Allen Black. The lawsuit was filed by patients who have dealt with short supplies of two drugs. One is Fabrazyme, a medicine used to treat a rare life-threatening genetic disease made by Genzyme and the other is Aquasol A, an injectable drug made by Hospira used to treat vitamin A deficiency. Both drugmakers have encountered numerous manufacturing problems.

GTx saw its shares plummet after regulators advised it to halt mid-stage trials on Capesaris, its possible treatment for advanced prostate cancer. The U.S. Food and Drug Administration told GTx to stop the trials after the company informed regulators that preliminary results showed an increased risk of blood clots in patients treated with Capesaris at doses of 1,000 milligrams or higher. The company has since suspended enrollment into the trials and has asked the trial centers to stop treating patients. GTx saw its shares fall 38.5 percent on the day of the news. The company said it plans to work with the FDA to determine the best way forward.

Pfizer suffered a setback in its attempt to expand the indication for its best-selling Prevnar 13 pneumonia vaccine when a federal advisory panel decided to postpone a recommendation until the conclusion of an ongoing clinical trial. Prevnar 13 was approved in 2010 to prevent infections caused by pneumonia in infants and children under the age of six, and generated $3.7 billion in sales last year. Pfizer was hoping to have Prevnar 13’s label expanded to include all adults aged 50 and older but the decision to wait for the results of the current trial might mean Pfizer will not receive a vote, one way or the other, until 2013.

Teva Pharmaceuticals will pay more than $250 million to settle more than 80 lawsuits that alleged that the company sold its Propofol anesthetic in vials that allowed doctors to reuse them, leading some colonoscopy patients to develop hepatitis C, Bloomberg reported. To date, Teva has resolved nearly 120 Propofol lawsuits and has reserved $270 million for the litigation cases while 15 lawsuits are still pending, according to a Teva spokesman.

The U.S. Food and Drug Administration has added 14 more Chinese companies to an import alert list, after discovering that the companies had supplied contaminated raw heparin in 2008. The raw heparin, a blood thinner, was linked to at least 80 U.S. deaths. The investigation into the crude heparin began in 2008 after batches of the drug were tied to hundreds of allergic reactions, some so severe that they killed U.S. patients. The FDA had previously added eight Chinese suppliers on its import alert list, which brings the total number of companies to 22. “The heparin supply is safe,” deputy commissioner Deborah Autor told the Wall Street Journal. “It’s one of the most protected drugs out there.”


February 24, 2012
http://www.burrillreport.com/article-patients_sue_u_s_agencies_over_drug_shortages.html