It’s getting increasingly difficult to know what is in your medicine cabinet. Worse, much of the drugs we take every day are contaminated, under potent or over potent. Sometimes, the drugs we take contain none of the active pharmaceutical ingredients (API) listed on the label.
To be fair, the majority of prescriptions meds on our shelves are safe but often they are manufactured in horrid factories, rife with bacteria and mold. And now… rust. The FDA this week took action against Vista Pharmaceuticals. The action followed a complaint of metal embedded in medication shipped to the United States.
FDA Visits Vista Pharmaceuticals
The FDA did a walk through inspection of Vista’s Hyderabad, India facility in September, 2016. The inspection resulted from a report of metal contaminated drugs. What the FDA found was quite scary.
FDA and European Union standards require pharmaceutical products to be manufactured in sterile clean rooms. There should be no contamination whatsoever. Even factory workers must shower and gown up before entering the manufacturing areas.
When the FDA visited Vista Pharmaceuticals, they found rusted out equipment riddled with corrosion and holes.
This isn’t the first run in that Vista had with the FDA. In 2015 the company was also cited by the FDA.
Vista Pharmaceuticals’ Troubles May Just Be Starting
Vista claims it has replaced the rusty equipment. The FDA isn’t ready to let them off the hook, however.
It appears that the drug reported to have been contaminated with metal was isoxsuprine hydrochloride. It turns out that Vista never bothered getting its isoxsuprine drug approved nor did it submit a validation process for the drug manufacturing process to the FDA.
The FDA can’t regulate and monitor the safety of drug products if the pharmaceutical companies fail to register with the agency. Regulators need to know what each plant produces and how that drug is made. Every step of the manufacturing process must be approved.
FiercePharma reports the FDA believes that the drugs made by Vista Pharmaceuticals plant in Hyderabad “appear to be identical, related, or similar to Vasodilan tablets which are the subject of a pending drug efficacy study implementation proceeding. The FDA said that it has learned of some adverse event cases that may be associated with use of isoxsuprine hydrochloride.”
Vasodilan, a brand name of the drug isoxsuprine, is a peripheral vasodilators used in the treatment of hypertension, acute myocardial infarction and heart failure.
Another problem is the labeling associated with Vista’s product. According to the FDA’s violation notice, the pills may be “misbranded.” The FDA deems products as misbranded its labeling fails to bear adequate directions for use. Under federal law, “adequate directions for use means directions under which a layman can use the drug safely and for the purposes for which it is intended.”
Pharmaceutical Whistleblower Awards
The FDA is understaffed. Inspectors are barely able to inspect every major manufacturing facility once every two years. Often the FDA must tell companies in advance of an inspection. That gives bad companies time to clean up, falsify testing data and hide problems. When a company fails to get FDA approval, the potential for abuse increases dramatically.
Under the federal False Claims Act, whistleblowers with inside information about fraud involving federal funds or programs may be eligible for large cash awards. Because most pharmaceuticals sold in the US are reimbursable through Medicaid, Medicare, Tricare of the VA, frauds involving these drugs may be prosecuted under the False Claims Act.
The FDA regulates drug manufacturing through what is called cGMP. Short for “Current Good Manufacturing Practices,” these practices cover virtually every aspect of the manufacturing and packaging process.
People make mistakes. A cGMP mistake is not fraud. Reporting mistakes may be helpful to prevent harm to the public but something more than mere mistake is needed to collect an award.
If you have evidence of a drug company hiding test results, making up test results, pressuring employees to overlook manufacturing problems, failing to properly test or fudging safety reports, you may be entitled to an award.
The False Claims Act pays awards of up to 30% of whatever the government collects from wrongdoers. Because the law makes drug companies pay triple damages, the awards can be huge. Awards in the millions or tens of millions of dollars are not uncommon.
Call for Vista Pharmaceuticals Whistleblowers
If you work or worked for Vista Pharmaceuticals, any API company of any other pharmaceutical company and have knowledge of cGMP fraud, off label use marketing or pay to delay schemes, call us. We have helped our whistleblower clients collect over $100 million in awards.
Not a U.S. resident or citizen? It doesn’t matter. Awards are payable to people anywhere in the world.
Worried about retaliation? The False Claims Act has strong anti-retaliation provisions. Unfortunately, U.S. courts only have jurisdiction over U.S companies and over foreign companies with facilities in the United States. For that reason, we work to protect your identity. Often, we can keep your identity private while the government is investigating. If the case goes forward, we can usually keep your name away from the press too.
Bad pharma threatens everyone. By reporting cGMP and other violations, you are helping keep people safe. Whistleblowers are the FDA’s best weapon against fraud and poor manufacturing practices. Help us, help you stop fraud. In return, we will work hard to get you the maximum award possible.
For more information, contact the pharma whistleblower lawyers at MahanyLaw. All inquiries are kept confidential and protected by the attorney – client privilege. We do not represent pharma, we represent you.
The author of this post, attorney Brian Mahany, can be reached at or by phone at (direct). Please also visit our pharmaceutical fraud whistleblower page. Our text searchable blog has dozens of other stories on pharmaceutical whistleblowers. Type in a company name such as Ranbaxy or Pfizer to learn more.
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