|
Drug Recall Problems with the FDA
The FDA has just removed a drug from the market; the reasons are interesting and should concern consumers, investors, generic drug companies—and the FDA. The FDA announced that the 300-mg generic version of Wellbutrin XL (manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals) was being recalled because it was ineffective. This problem has been going on with this particular drug for four or five years, a fact ignored by the FDA.
It appears that the FDA approved this drug, and others, without testing it. The FDA assumed that if a dosage strength (submitted by the drug companies) worked, then the other higher dosages should also work.
In December 2006, the first generic versions of Wellbutrin XL 150 mg and 300 mg were approved by the FDA. The 300-mg dose is generally used for patients with more severe depression and anxiety as well as for patients who don't respond to the lower dose. The FDA approved generic versions of both dosage strengths from Teva Pharmaceuticals (manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals), Anchen, Actavis, Watson Pharmaceuticals, and Mylan Pharmaceuticals. The FDA started receiving reports from patients that claimed the 300-mg dose was being associated with side effects and reduced efficacy almost immediately.
The People's Pharmacy, a well-known syndicated radio and newspaper columnist, notified the FDA that hundreds of patients had logged their own complaints of side effects with the then-recently approved generic version of Wellbutrin XL. The FDA ignored the reports as well as others that raised the issue, stating that they had faith that the drugs were equivalent; they responded that perhaps the patients, who had mental disease, were more prone to perceive problems with a change in the medication than others. After several more years and public outcry, the FDA was then forced to take action.
The FDA asked the sponsor to conduct a study to determine the equivalency of the generic to the brand. The FDA states that Teva started the trial but abandoned it because few patients enrolled as participants. By now it was already 2010, several years after knowing there was a problem, and the FDA had to conduct their own study, which was completed in August 2012—more than 5 years after the initial problems were reported. The study showed that the 300-mg dose from Teva did not deliver a sufficient amount of the drug. Despite the results being available in August 2012, the public was not made aware of the results until October 2012.
The FDA issued its press release on October 3rd and said that the FDA made a mistake in that it had taken the data for the 150-mg version, and, since that dosage had worked fine, they just assumed that the 300-mg dosage would also work and subsequently approved the drug.
Now, the FDA has approved five generic versions of Wellbutrin XL 300 mg; each was approved based on bioequivalence studies comparing the 150-mg strength of the products to Wellbutrin XL 150 mg. Studies were not performed on the 300-mg strength. Now, the FDA has determined that this approach is inappropriate to establish bioequivalence of 300-mg bupropion hydrochloride extended-release tablets to Wellbutrin XL 300 mg, and the FDA is revising its guidance to industry.
The wording on the press release hides the fact that this method of approving Wellbutrin XL or any drug is not only "no longer" appropriate, but was never an appropriate way of approving drugs. The FDA did not remove the other drugs that were approved with the same faulty approach and has now asked the other generic drug companies to perform these tests for the FDA and submit the results by March 2013. With the earlier problems, it seems more appropriate that the FDA conduct these tests and immediately remove the other generics while awaiting the results of the testing; the name-brand drug is still available.
The lack of efficacy is a safety issue, and a question arises "How many patients who were not adequately treated on the 150-mg dose were put on the 300-mg dose only to see their symptoms get worse because the generic did not work as promised? How many patients, doctors, and their families thought that this was simply a further deterioration of a patient's condition and mental state? How many parents had to worry about their children when their anti-depressant seemed to stop working? How many people committed suicide taking a generic antidepressant that did not work?" This fiasco could have been prevented if the FDA had simply tested the drug before they approved it or, at the least, investigated the hundreds of complaints they received.
http://www.forbes.com/sites/davidmaris/2012/10/10/fda-recall-points-to-serious-problems-at-the-fda/
Dissolving Microneedles Deliver Transdermal Insulin
The dissolving microneedle (DM) application system consists of 225 to 300 insulin-loaded DMs that were formed on a chip. After a heat-sealed sheet is removed, the system covered with the press-through package layer is put on the skin. By pressing with the hand, insulin DMs are inserted into the skin. The in vivo penetration depth was dependent on the force and duration, as the secondary application force. These results suggest the usefulness of the two-layered DM application system for the transdermal delivery of insulin
http://www.ncbi.nlm.nih.gov/pubmed/23013202
| 
