FDA Delays Regulation to Restore Legal Rights for Consumers Hurt by Generic Drugs

For several years, a legal battle has waged over whether generic drug manufacturers may change warning label information if the brand name drugs they replicate have not done so. So, to protect consumers from court rulings that left them vulnerable, the FDA proposed a regulation allowing generic drug makers to update their labels before receiving the agency’s approval. But now, the feds have delayed that action.

The problem with hamstringing companies that know their products might be harmful was described in our blog last year about a woman who took a generic drug for shoulder pain, and landed in a burn unit for two months in a medically induced coma when it had a devastating effect on her skin.

Permanently disfigured, she sued because the drug was “unreasonably dangerous,” and learned she wasn’t the first person to have suffered an adverse event – it was known that the generic drug’s rate of life-threatening conditions was comparable to another drug the FDA had recommended be removed from the market.

The U.S. Supreme Court originally prohibited injured patients from suing generic drug companies because the information on labels was deemed to be the exclusive responsibility of the pharmaceutical companies that developed the brand name drug. The court said that if the generic manufacturers are prohibited from printing warnings about drug side effects, patients shouldn’t be able to sue them when bad things happen after taking the drug.

As described in the Wall Street Journal’s Pharmalot blog, last year the FDA proposed a rule to allow generic drug makers to update safety warnings as they determined a need to do so. The rule was supposed to be finalized next month, but now, it won’t be published until nearly a year from now.

The questionable character of this industry was described last week on the civil justice site PopTort. It called out Ranbaxy, the country’s sixth largest generic drug maker, which has a history of “fabricating data, lying to regulators and forging documents.”

It took the FDA years to stop approving the compromised Ranbaxy drugs, and when it did, the company sued, claiming the feds had violated its constitutional rights and deprived it of rightful revenue.

“You see,” PopTort observes, “Ranbaxy believes it has a constitutional right not only to make money but also to sue to enforce that right. But anyone killed or injured by unsafe Ranbaxy drugs? They should have no legal rights at all, apparently.”

The proposed regulation, FDA officials have said, was meant to “create parity” between brand-name and generic drug makers. “Since the passage of the 1984 Hatch-Waxman Act,” Pharmalot noted, “generic drug makers have not been required to run tests to prove their medicines are the same as brand- name drug and, therefore, have not had to upgrade labels with safety information.”

The consumer advocacy organization Public Citizen, which had lobbied the FDA to address the generic labeling restriction that harmed people, wasn’t pleased about the delay. Pharmalot quotes Allison Zieve, head of the litigation group at Public Citizen: “The extra nine months or so of delay allows a safety gap to continue that can only lead to harm. No drug is safe in all situations. A drug is safe when used in accordance with labeling that accurately reflects the known risks. The sooner generic drug companies are allowed to make safety updates, the better for public health.”

Generic drug manufacturers protected by the Supreme Court’s ruling are concerned that the proposed rule will encourage lawyers to find situations that appear to be negligence if the drug makers don’t act quickly enough to add warnings to product labeling.

Well, shouldn’t potential cases of negligence be investigated and, if necessary, pursued? Do these companies truly think personal injury lawyers, who are paid only if they can prove their cases and win judgments for their harmed clients, have time to poke around in search of questionable events? So-called “ambulance chasers” make good fictional villains, but drug-harm litigation is long and laborious, and it’s ridiculous to think legions of people engage in it on spec.

The Generic Pharmaceutical Association, the industry’s trade/lobbying outfit, issued a think piece that concluded that such litigation could add $4 billion to the nation’s annual health-care bill, and that its survey of 450 physicians, physician assistants and pharmacists showed that the proposed rule would require additional time to keep current with labeling changes.

Yeah, doing the right and responsible thing can be time-consuming. Often, it’s faster just to slide dangerous products into the marketplace, and hope for the best.

According to Pharmalot, “The contentious nature of the debate [consumers versus drug makers] is apparently the reason for the delay. An FDA spokeswoman wrote us that the ‘FDA received a great deal of public input from various stakeholders during the comment period on the proposed rule. We are committed to reviewing and considering all of the comments received as we develop the final rule.'”

That sounds like the feds caved into industry pressure, not that the delay reflected prudent reconsideration.

If you think political leaders are lining up behind consumer safety, think again. “[S]ome lawmakers have questioned the authority of the FDA to propose such a rule,” Pharmalot reported. A House committee report said the rule has “the potential to threaten public health by creating unprecedented patients and provider confusion by having multiple labels for the same product,” which, according to Pharmalot, “would undermine a policy of having the same label for brand and generic drugs.”

So a better policy is to let the potential serious harm go unrecognized?

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