GOVERNMENT & POLICY
more than 100 comments it has received on its proposal and will then decide whether to make the rule final or make changes and issue a revised measure. “More than 80% of prescriptions filled in the U.S. are for generics, so we want to make sure that generic drug companies acGENERIC DRUG MAKERS fear FDA proposal would spur tively participate with FDA to ensure that litigation, lead to confusion in the marketplace product safety information is accurate and GLENN HESS, C&EN WASHINGTON up to date,” Woodcock continues. In addition, consumer advocates say the proposed change is vital because there are FOR NEARLY THREE DECADES, generic are allowed to update their warning labels more than 400 generic drugs on the market drug companies have relied on safety labels if they receive reports of adverse reactions for which there is no longer a brand-name from the makers of brand-name medicines in patients. Generic drug makers, however, counterpart. Serious side effects associto warn consumers about product risks. In are prohibited from revising product labels ated with prescription drugs are often not fact, Food & Drug Administration regulawith new warnings, until and unless FDA apdiscovered until the medication has been tions require that generic drugs carry the proves a name-brand drug label change first. on the market for years. same warnings and precautions as their Doing away with that requirement is “If generic manufacturers are not acname-brand counterparts. needed to “create parity” between brandtively monitoring and proposing safety Now—citing issues of balanced risks updates, no manufacturer is doing for drugmakers and transparency for so at all,” says Allison M. Zieve, genCHANGES FDA is considering a new rule for doctors and patients—FDA wants to eral counsel at Public Citizen, a drug drug safety labels. change the regulations so that generic safety watchdog group. Giving generic drug manufacturers will be motivated drug makers more responsibility for to take greater responsibility for their labeling will encourage vigilance and CURRENT RULE PROPOSED RULE products. Specifically, FDA has proshould help to prevent injuries from Generic drug makers Generics firms posed a rule change that would allow geoccurring in the first place, she adds. are not allowed to would be allowed neric drug companies to independently independently update to update product warn consumers when important new OPPONENTS OF the proposed rule, the warning labels on labeling on their own safety information surfaces about one however, contend the new requiretheir medicines; they with newly acquired of their drugs. It would remove a shield ments would expose generic drug can only copy an FDAsafety information from product liability claims that curmanufacturers to new legal liability approved change already before FDA’s review rently protects generics manufacturers that will increase the prices of generic made by the brandof the change. from personal injury lawsuits. medicines and create confusion by name manufacturer. Generic drug manufacturers are not making warning labels inconsistent happy with the proposal. among multiple generic versions of “New labeling regulations should a brand-name drug. “FDA’s proposal protect patients, facilitate care, and writes a prescription for mega lawreduce costs,” says Ralph G. Neas, chief suits against generic drug makers by executive officer of the Generic Pharplaintiffs’ lawyers alleging that generic maceutical Association (GPhA), an inlabels are somehow inadequate,” dustry lobbying group. “Unfortunately, says Lisa A. Rickard, president of the the proposed rule does none of these Institute for Legal Reform at the U.S. things—the unintended consequences Chamber of Commerce. “It is unfortuof this rule would be nothing short of nate that FDA is considering a change catastrophic.” that could drive up the cost of generic Rather than benefiting public health, drugs, perhaps by billions of dollars.” critics say the new rule would mostly This situation has been shaped by a profit personal injury lawyers because pair of Supreme Court rulings. of the generics manufacturers’ new In 2009, the Supreme Court conlegal exposure. firmed in Wyeth v. Levine that a brandFederal law requires generic drugs name pharmaceutical company could to be essentially the same as their brandname and generic drug makers regarding be sued for failing to warn patients that name counterparts. Both products must product labeling, says Janet Woodcock, a drug it developed carries a serious pocontain the same active ingredient; be director of FDA’s Center for Drug Evaluatential health risk. But two years later, the identical in dosage form, strength, and tion & Research. It would also help to betjustices ruled in Pliva Inc. v. Mensing that route of administration; and also have the ter inform doctors and their patents about a generics manufacturer couldn’t be held same safety-related labeling information. potential hazards, supporters say. liable for failing to include adequate warnBrand-name pharmaceutical companies FDA is in the process of reviewing the ings in its product labeling. ISTOCKPHOTO
LABELING RULE STIRS DISCORD
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“The unintended consequences of this rule would be nothing short of catastrophic.” Justice Clarence Thomas, writing the majority opinion in Mensing, acknowledged that the distinction between generic and brand-name drugs “makes little sense” from the perspective of injured patients. But the court held that the makers of generic drugs must use the same labels as the corresponding brand-name drugs and thus could not be blamed for failing to warn patients about the risks of taking their drugs. In dissent, Justice Sonia Sotomayor wrote that “a drug consumer’s right to compensation for inadequate warnings now turns on the happenstance of whether her pharmacist filled her prescription with a brand-name drug or a generic.” Since the ruling, state courts have dismissed dozens of related lawsuits. UNDER THE PROPOSED RULE, FDA
would evaluate whether a change for a generic drug label is justified and then make an approval decision that would apply to the generic and brand-name versions of the drug. This would ensure that both forms have identical prescribing information. For now, if a generic drug company becomes aware of a potential risk not stated in the labeling, all it can do is pass the data along to FDA and the brand-name manufacturer. It must then wait until the agency makes a decision on a label revision for the corresponding brand-name drug. Practically speaking, this means that “all updated safety information runs through FDA and the brand-name manufacturer,” says Julia M. Rafferty, an attorney at Stradley Ronon Stevens & Young. FDA’s proposal would place equal responsibility for monitoring drug safety on the brand company and the generics manufacturers. “The goal is to make sure the whole system is searching for safety problems and updating labels when they are found,” Woodcock says. The agency’s proposal would also pave the way for lawsuits from injured patients who could now claim that generic drug companies did not sufficiently warn them about the risks of taking their drugs. A generics manufacturer would have an “independent responsibility to ensure its product labeling is accurate and up-to-date,” according to the proposed rule. This exposure of generic drug manufac-
turers to substantial new tort liability costs, in turn, “would require them to adjust prices to stay in business, withdraw products, or decline to launch new affordable versions of brand medicines,” Neas contends. Perhaps most troubling, he asserts, is that the rule as currently written would allow different labeling for multiple generic versions of a brand-name drug, even though the medicines are chemically identical. “This would cause dangerous confusion and have harmful consequences for patients, prescribers, pharmacists, and others throughout the health system,” Neas remarks. Gordon Johnston, a former deputy director of FDA’s Office of Generic Drugs and now an industry consultant, agrees, saying the proposal directly undermines the “sameness” requirement for generics and their brand-name counterparts. “Disregarding decades of regulatory stability in this way will create unwarranted confu-
sion, raises patient safety concerns, and threatens the system that created thousands of affordable options for consumers,” Johnston says. But Woodcock points out that the current system allows for temporary labeling differences between brand-name drugs and their generic equivalents. After FDA approves a revision for a brand-name medicine, it can sometimes take more than a year for generic drug makers to subsequently update their labels, she says. The proposed rule calls for all labels to be conformed within 30 days, so doctors and their patients would be warned about potential risks and side effects more quickly, Woodcock says. “FDA believes it’s time to provide generic drug makers with the means to promptly update their labels,” she remarks. GPhA has suggested a compromise in which the industry would actively assist FDA in deciding whether label updates are needed on the basis of newly discovered side effects. But generics manufacturers would still need the agency’s permission to make modifications. ◾
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