Much of the FDA’s energies are currently focused on pharmaceutical manufacturing in China and India but that doesn’t mean that everything in the United States smells like roses. Earlier this year FDA inspectors cited Pyramid Laboratories with numerous cGMP violations. Short for “current Good Manufacturing Practices,” cGMP regulations are designed to insure that the drugs we purchase are safe, unadulterated and fresh.
In January, FDA inspectors spent over a week inspecting Pyramid Laboratories of Costa Mesa, California. Recently, the agency cited the company with 13 findings. None of the violations warranted shutting down the company but the findings were still quite serious.
Included in the findings were several “action level environmental excursions.” That means sterile areas of a facility may have been compromised by outside microbes or contaminants. The FDA requires more serious excursions be investigated and corrected.
The FDA was also concerned that employees were not properly trained to inspect both the company’s final products and sterile biologics. Government inspectors found newer employees were held to a lower standard than required.
The FDA also faulted the company for not having test results for certain ingredients and not conducting proper monitoring during the manufacturing process.
Pyramid Laboratories is a contract manufacturer meaning it produces pharmaceuticals for other companies. Much of its product line involves sterile injectables. These drugs are much more difficult to produce. Because many are injected directly into the blood stream, keeping the drugs sterile and of the highest quality is important.
Although the FDA’s cGMP violations involving Pyramid Laboratories may not sound serious to some, the agency does not routinely inspect and test pharmaceuticals sold in the United States. Instead, it relies on the industry to adhere to a rigorous regimen of proper manufacturing practices and self-testing. Failure to monitor the manufacturing process or require testing on active ingredients can result in contaminated, understrength or adulterated products reaching the market.
In 2012, FDA inspectors found insect remains in some vials used for the manufacture of injectable drugs. That violation was not related to Pyramid.
Because Medicare and Medicaid cover most pharmaceutical drugs, whistleblowers can receive compensation for reporting cGMP and other violations. A federal appeals court decision suggested that in order to receive an award, there must be both a violation of FDA rules and evidence that an adulterated drug was produced.
Under the federal False Claims Act, whistleblowers can receive up to 30% of whatever is collected from wrongdoers. Given the cost of prescription drugs, it shouldn’t be a surprise that most of the largest whistleblower awards have involved cases against the pharmaceutical industry.
If you have evidence of cGMP violations, poor pharmaceutical manufacturing, pay for delay schemes or drugs being marketed for off label use, give us a call. Our whistleblower clients have received over $100,000,000.00 in awards. Last year the government paid out almost $700 million to whistleblowers and that figure doesn’t include awards by the many states with false claims acts.
MahanyLaw – America’s Fraud Recovery and Whistleblower Lawyers