Not too many years ago, most pharmaceuticals were manufactured in the United States. That is no longer true. Today 85% of the drugs in our medicine cabinet are made outside the United States. Often in countries with little oversight. One survey suggested 25% to 40% of drugs made in India are “sub-standard.” Even the few drugs made here are often made in unsanitary conditions. There is no way the FDA can police tens of thousands of pharmaceutical and API manufacturing facilities alone. Only with the help of FDA whistleblowers – that’s right, company insiders – can we be assured of safe drugs and fair prices.
Clean rooms that are anything but clean or sterile. Adulterated, over potent or understrength drugs and poor cGMP (current good manufacturing practices) are just part of the problem. Add pharmaceutical companies that encourage doctors to push drugs for unsafe or non-approved purposes, kickbacks, over pricing and pay to delay schemes and it easy to see that the pharmaceutical industry isn’t what it once was.
Standing in the between patients and corporate greed are the production workers and compliance professionals. Most come to work every day and do their job as best they can.
And when they are told to fudge test results, or when they fail lots of drugs only to have management overrule their decisions, problems occur. Ditto for the sales reps who are pressured into pushing drugs for uses not approved by the FDA.
We have seen it all. And if you work for a drug company, so have you.
Our whistleblower clients tell us the first thing they feel is anger. How can this be? Why are we offering kickbacks? Why are we promoting off label use? Or why are we conspiring with some others to keep prices beyond the means of most consumers?
Usually, the anger leads to frustration. Good workers try to address problems internally. When that doesn’t work, some throw up their hands, some leave while others try to escalate the problem with senior management. “Maybe if my boss’ boss knew what was going on she would intervene. Surely the company wouldn’t allow drugs with potency problems to hit the marketplace.”
Nothing seems to happen, however. Days become weeks become months. Then the apathy sets in. You learn that if you want to keep your job, you just keep your mouth shut. You hope things will change. They don’t. Some workers, sales reps and QA professionals find other jobs. Others stay although both demoralized afraid to rock the boat any harder.
But a few become whistleblowers. They are the new American heroes. And in increasing numbers, those whistleblowers are QA professionals. When big pharma hires compliance workers, they better be prepared for the backlash if those workers are ignored.
In increasing numbers, workers are feeling empowered and taking matters into their own hands. They are becoming FDA whistleblowers. The big pharmaceutical companies know this and are trying to make it harder to become a whistleblower.
Big pharma – and even the Chinese, Indian and other offshore generic companies and contract manufacturing plants – are amping up the pressure to keep employees in line.
How? Employment agreements that suggest it is a HIPPA violation to send records to the FDA. Employment agreements that say you can’t sue the company for whistleblower retaliation and even agreements that suggest that you can’t report misconduct to the government! Many times, these agreements are illegal (they are certainly unethical) but employees are afraid of being singled out or losing their job.
Take for example HIPPA. Pharmaceutical companies often scare workers with possible prosecution for HIPPA violations. What they fail to say, however, is that there are exemptions for reporting misdeeds to regulators, law enforcement and disclosures to one’s own legal counsel.
Recognizing the hardships faced by FDA whistleblowers, Congress established the False Claims Act to provide financial incentives to those that do step forward. Under the Act, whistleblowers can keep 15% to 30% of whatever the government collects from the wrongdoers.
How big are those awards?? In the five years since May 2012, pharmaceutical companies under the False Claims Act cases have paid over $19,000,000,000.00. That’s right, $19 billion. With awards of between 15% and 30%, that equates to billions of dollars for FDA whistleblowers!
- GlaxoSmithKline $2 billion
- Johnson & Johnson $1.720 billion
- Pfizer $1 billion
- Abbott $800 million
- Wyeth & Pfizer $786 million
- Merck $650 million
If you have knowledge of a pharmaceutical manufacturer, compounding pharmacy, drug company or distributor that is defrauding the FDA, Medicare, Medicaid or Tricare, contact us immediately. We are ready to help you stop the fraud or unsafe practices and to make sure you get the highest award possible.
Even if you are not ready to blow the whistle or just want some answers, call us. We never charge for consultations and our services are 100% CONFIDENTIAL. Even if you don’t hire us. For more information, contact us online today.
Off Label Marketing
When the FDA approves a prescription drug, that drug is approved only for specific conditions or ailments. Pharmaceutical companies must prove to the FDA that their formulations are safe and effective. Even the manufacturing process for drugs must be approved.
Drug companies spend tens of millions of dollars each year on clinical studies and trials. It could take years before a new drug is approved or an existing drug is approved for a different condition.
Doctors, however, are free to dispense prescription drugs in ways not approved by the FDA. That practice is called an “off label” use. Drug companies can’t encourage or assist in such practices. Many do, however, because it saves them saves years of waiting for FDA approvals. It also allows them to rake in billions of dollars of additional profits.
Some drug companies encourage their sales reps to promote off label use of drugs. Some do so directly while others pressure their sales reps so much that the only way a rep can make her quota is to push drugs for off label uses.
We have many stories on our website about FDA whistleblowers who have earned cash awards for reporting off label use violations. (Use the search feature of our Due Diligence blog.)
In July 2012, GlaxoSmithKline paid $3 billion to settle a variety of charges regarding kickbacks and off label uses of their pharmaceutical products. $1,043,000,000.00 of the settlement was attributable to whistleblower claims regarding off label use of several GSK drugs. Specifically, the FDA and Justice Department said the company was “promoting the drugs Paxil and Wellbutrin for unapproved, non-covered uses, GSK also promoted its asthma drug, Advair, for first-line therapy for mild asthma patients even though it was not approved or medically appropriate under these circumstances. GSK also promoted Advair for chronic obstructive pulmonary disease with misleading claims as to the relevant treatment guidelines.”
Another aspect of the case involved alleged kickbacks paid by GSK to physicians to encourage them to prescribe more of their products.
Federal law and Medicare regulations prohibit drug companies from offering doctors compensation or things of value in exchange for prescribing a company’s drugs. The kickbacks need not be in cash. We have seen cases involving phony medical directorships, speaking fees, research grants where there is no expectation of any research, expensive meal and even trips for staff within the doctor’s office.
Yet another form of illegal behavior involves tying arrangements. Some drug companies will offer steeply discounted discounts on certain medications in exchange for writing more prescriptions of different, more profitable drugs.
Clinical Trial Fraud
Some of the worst frauds we have encountered in the pharmaceutical world involve clinical trial frauds. As noted above, the FDA typically requires every new drug and every new use for an existing drug to be extensively tested. There are human studies, animal studies, and lab work needed before drugs can be approved. These procedures are done for a variety of reasons including to measure how quickly the drug degrades or loses potency. They also involve safety studies to make sure there are no unintended drug interactions. All this can take years and cost millions of dollars.
A few very greedy and unethical companies will fudge the data. That is clinical trial fraud and is not only illegal, it could be deadly. Many companies will engage in a less obvious form of clinical trial fraud. They do so by not reporting adverse reactions or product failures. The results can be just as deadly for patients.
Other companies try to suggest that their medical devices are substantially equivalent to existing approved devices or that their pharmaceutical product is biosimilar. They do this to avoid costly testing or to have less testing. That is legal if the products really are the same.
Perhaps the largest danger for the general public comes from adulterated, mislabeled or under- / over potent pharmaceutical products. And who is in the best position to see these violations? Line workers and QA professionals.
In 2010, SB Pharmco Puerto Rico, Inc., a GlaxoSmithKline affiliate, paid $750 million in fines and penalties to settle claims about misbranded and adulterated Paxil CR and Avandamet drugs. The government said the charges arose under the False Claims Act and stemmed from cGMP problems. Specifically, prosecutors and the FDA claimed that some Paxil CR tablets that lacked any active ingredient, and some that lacked any controlled release mechanism. The FDA also claimed some Avandamet tablets did not contain the FDA-approved mix of active ingredients.
How did the government find out about these cGMP violations? FDA whistleblowers, of course!
More recently, in 2017 the FDA and Justice Department resolved another cGMP case, this one involving Baxter Laboratories. The government said that HEPA air filters in the sterile “clean room” area of the company’s manufacturing facility had visible mold, a serious cGMP violation. The company paid $18 million even though there was no evidence that any drugs were actually contaminated.
Call for FDA Whistleblowers
In 2017, the International Journal of Health Services reported that over the last 18 years, some 112 million prescriptions were written for drugs that turned out to be unsafe. Those are the prescriptions that the FDA knows about. Millions more drugs are in our medicine cabinet, pharmacy shelves or hospital dispensaries today that are adulterated, under-potent, mislabeled or unsafe. Millions more of prescriptions have been written by doctors on the mistaken belief that certain drugs are safe or effective for uses where the FDA has no evidence of such.
The public is being endangered simply so some billion dollar drug company can squeeze out a few more dollars of profit or avoid the embarrassment of a recall. This where dedicated pharmaceutical industry workers, managers, QA professionals and pharmaceutical reps can make a real difference.
Not only are large cash awards available, under the False Claims Act and related SEC whistleblower laws, retaliation is illegal.
Call us today if you are interested in becoming an FDA whistleblower. Even if you decide not to report, learn your options. All inquiries are protected by the attorney – client privilege and will remain totally confidential.
The call is free. The consultation is free. Even if you are outside the United States or not a citizen, you are still eligible for an award.