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Delay of drug labeling policy can make generic drugs more dangerous

Several Americans who say they’ve been dangerously harmed by generic drugs — and were unaware of the risk because the drug maker did not publicize those potential safety concerns — are pressuring the FDA to crack down on this sector of pharmaceutical industry, which is currently shielded from lawsuits.

At a public hearing on Friday, patients will ask the Food and Drug Administration to implement a rule change for generic drug labels that would resolve a controversial fight over the issue that’s stretched on for the past several years.

Pharmaceutical companies are required to track any adverse health effects that occur as a result of using their products, since the full range of potential side effects don’t always emerge in clinical trials before drugs are officially approved. But, thanks to the complex nature of prescription drug regulations, generic drug makers are not currently required to update their warning labels when they learn about new risks associated with their products. They can only go through the label update process if the FDA specifically asks them to make changes — which is rare, since the agency doesn’t necessarily have the resources to closely monitor the thousands of drugs that are on the market.

That’s why, although studies have documented a potential increased risk of blood clots stemming from birth control pills that contain the hormone drospirenone, Tammy Smoot didn’t think twice when her teenage daughter started taking a generic version of Yaz to regulate her monthly cycles. She didn’t know that some consumer advocate groups have steered women away from drospirenone pills, advising them to use a different type of hormonal birth control that doesn’t carry the same risks.

After a few months of taking the pills, Smoot’s daughter, Taylor, developed a series of severe blood clots. Since then, she has been in and out of the hospital and has undergone 17 different surgeries. “I can’t do sports anymore. I have eleven stents in my legs and my stomach, so I can’t walk for long distances without my leg and my groin hurting,” Taylor, who’s now seventeen years old, told ThinkProgress.

Bayer Healthcare Pharmaceuticals, the manufacturer of the brand-name pill, has paid out more than $1 billion to thousands of U.S. plaintiffs who allege that drospirenone caused life-threatening blood clots. But the Smoots don’t have the same legal recourse because Taylor was taking the generic version. Thanks to two recent Supreme Court rulings in 2011 and 2013, generic drug makers are not liable for failing to advertise potential risks on their labels — even if the industry knew about them — because current FDA protocol does not permit them to update their warnings on their own.

Before those Supreme Court decisions, generic companies were sometimes sued and found liable for damages. But now, they’re largely shielded from consequences in this area. As generic drugs have swelled to 80 percent of the prescription drug market, to the point where there aren’t any brand-name equivalents available for some of them, the justices have essentially blocked lawsuits from patients like the Smoots. Tammy Smoot contacted a lawyer, but she said “his hands were pretty tied” on the issue. “These generic drugs are being protected. If these drugs hurt you, oh well, there’s nothing you can do about it,” she said.

Consumer advocate group Public Citizen says that, without the risk of litigation, generic drug makers have little reason to ensure they’re publicizing the potentially dangerous side effects that could result from their products.

“They no longer have an incentive to monitor the safety of their products and make sure warnings are up to date,” Dr. Michael Carome, the director of the health research group at Public Citizen, told ThinkProgress. “That ultimately presents a significant safety threat to patients.”

After the 2011 court ruling in this area, Carome’s group petitioned the FDA, pressuring the agency to allow generic drug companies to more easily warn patients about health concerns. The effort was successful. In the fall of 2013, the agency proposed a rule that would grant generic drug makers the ability to independently update their safety warnings, something that’s currently limited to brand-name medications.

But the FDA has repeatedly delayed finalizing the rule — eventually deciding to re-open the comment period and give its critics another chance to weigh in. Sandy Walsh, a press officer for the FDA department that handles generic drugs, told ThinkProgress via email that the agency is “carefully reviewing numerous comments submitted to the public docket established for the proposed rule from a diverse group of stakeholders” and will “determine next steps based on our analysis of the comments.”

The advocates at Public Citizen are concerned that the FDA is taking so long to implement the rule because the agency is facing too much pressure from the prescription drug industry, which has been fiercely critical of the proposed change. The Generic Pharmaceutical Association (GPhA) released a study estimating that making it easier for patients to sue over outdated labels could cost the industry an additional $4 billion per year in litigation fees.

“This is a very simple rule change, but it’s being strongly resisted by the industry,” Carome said. “With every delay, more and more time passes in which patients are being put at risk.”

In addition to pharmaceutical groups, some members of Congress have also raised concerns about the rule change. The House Appropriations committee released a report this past summer arguing that the proposed rule “has the potential to threaten public health by creating unprecedented patient and provider confusion by having multiple labels for the same product.” (Proponents of the policy say that some labeling differences already exist.) State attorneys general, on the other hand, have pushed for the new rule as a way of preventing medical costs stemming from defective drugs.

Taylor Smoot, who’s planning to testify at the FDA hearing on Friday, thinks one solution would be to remove some of these drugs from the market altogether. “I don’t want any of this to happen to anyone else,” she said.


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