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Ranbaxy Consent Decree
A January 25 consent decree filed by the Department of Justice on behalf of FDA against Ranbaxy is making news for its provisions. The consent decree, described as “unprecedented in scope” by the Department of Justice, addresses Current Good Manufacturing Practices (cGMP) violations that have been ongoing at three Ranbaxy facilities in India as well as at Ranbaxy-owned Ohm Laboratories. Manufacturing of products for the U.S. market will be stopped at the four plants until the cGMP issues are corrected. Ranbaxy will also be required to comply with a number of provisions, including the withdrawal of applications found to contain problems, third-party audits, and relinquishment of 180-day marketing exclusivity for at least three products. FDA is reserving the right to extend the consent decree to other Ranbaxy facilities should further problems be identified.
Learn more about this situation with our list of relevant inspection documents.
FDA Whistleblower Lawsuit
Six former and current FDA employees filed suit against the agency January 25 in U.S. District Court. The lawsuit alleges that the agency improperly monitored personal email accounts and retaliated against the employees (in some cases, by firing them) based on information gathered from the surveillance.
The employee monitoring in question began in January 2009 after the group of six scientists wrote a letter to incoming President Obama alleging corruption within FDA and asking for an investigation. The scientists concerns were rooted in the belief that the agency had been approving medical devices which had not been proven effective or which carried unacceptable safety risks. One example included a breast cancer screening device that was repeated recommended for non-approval based on lack of scientific proof that it effectively detected cancer and concerns that it would lead to unnecessary, potentially dangerous follow-up procedures. The device was approved anyway, amidst “ordering, coercion, and intimidating” of FDA employees and retaliation against those who still recommended against approval, according to the group of scientists. Prior to writing to the President, the six scientists had been making complaints, first within FDA and then to Congress, about this and similar device approval situations for over a year.
The new lawsuit alleges that, despite warnings on federal government computers that there is no “reasonable expectation of privacy” for users, the agency’s actions violated the scientists’ Constitutional right to privacy by monitoring activity which was not illegal. The agency is countering that the six employees acted improperly and even illegally by disclosing confidential business information regarding medical devices to outside sources. FDA twice requested an investigation into the scientists’ actions in 2010, but was rejected both times by the Health & Human Services Inspector General.
Read more about this and other whistleblower situations with our list of relevant documents which includes copies of some of the emails and other communications monitored by FDA.