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Editor: Bob Binstock, Attorney at Law
Profession: Defective Medical Device Attorney

Category: Hernia Patch Recalls

The FDA recalled the Kugel Mesh Hernia Patch after it was discovered that the patch's memory recoil ring was predisposed to breakage. The post approval adverse event reporting system used by the manufacturers was cited as being in adequate and resulted in a delayed response because the FDA was unaware of complications with patches. This in addition to the controversy surrounding prescription medications has prompted a new bill that has already been passed by both houses of Congress, and will hopefully give the FDA a much better opportunity to make sure that events like this are not soon repeated.

The new bill will now be up for approval by the President where it is expected to be signed into law. The proposed bill will grant the FDA much greater authority to combat the strong pharmaceutical lobby. The FDA will be able to force companies to perform post approval clinical trials and have the ability to assess fines if a company does not comply as ordered.

The bill will also allow for an increase in funding for the administration and increase the fees that companies pay when submitting new drug applications. The best part about the bill is that will create a web-based database that will allow the FDA to monitor all clinical trials of drug companies. Companies will be required to post the results of clinical trails after their conclusion. This registry will be maintained by the National Institutes of Health and will be accessible to anyone with an Internet browser.

Drug companies likely will soon be experience much higher levels of scrutiny form both the FDA and the public. Hopefully this new bill, if passed into law, will grant the FDA the much deserved authority it needs to ensure that the medical device and prescription drug market is upheld to the highest levels of scrutiny available.