Lawyering Up Over Labels
On November 13, 2013, the Food and Drug Administration (FDA) released a proposed rule that would allow generic pharmaceutical firms to provide new safety information and update a drug’s label without first getting FDA approval, even though doing so would make it different from the reference drug’s (the original brand-name) label. If the proposed rule should go in effect, it is conceivable that several versions of labels for the same medication could exist, creating uncertainty for physicians, pharmacists, and patients.
The FDA decided to issue the proposed rule because of Supreme Court decisions in Wyeth v. Levine, 555 U.S. 555 (2009); Pliva, Inc. v. Mensing, 564 U.S. __ (2011); and Mutual Pharmaceutical Co., Inc. v. Bartlett, 570 U.S. 2468 (2013). The cases resulted in providing individuals with the ability to bring a product liability action for failure to warn about possible drug risks against the brand-name company, but generally not the generic company. The FDA claims the new regulation is to “create parity” between brand-name and generic companies with respect to submitting new safety information to the agency for review. In other words, cases could be brought against either type of pharmaceutical company.
While generic companies are already required to report adverse drug events to the FDA, they are prohibited by law from making any changes to a drug’s label unless the brand-name company changes the label first. After all, generic companies are required by statute to have the same label as the branded drug they are copying in order to demonstrate to healthcare professionals that the drugs are bioequivalent. Thus, the proposed rule represents a 180-degree change from what the FDA has espoused for more than 30 years. Adoption of the rule would also mean that generic companies could be held legally responsible for any “failure to warn” tort cases.
The rule would have two significant adverse results. First, it would create is a huge opportunity for trolling trial lawyers. Second, according to a 2014 study by Matrix Global Advisors, adoption of the proposed rule would increase the cost of generics by $4 billion per year: $1.5 billion in government health programs and $2.5 billion in private plans.
When the FDA approves the manufacturer’s drug label, it is doing far more than just allowing a piece of paper to be glued to a bottle with instructions on when and how to take the drug. The FDA website states, “Labeling is based on the agency’s thorough analysis of the new drug application (NDA) or biological license application.” The primary purpose of the label is to give health professionals the information they need to prescribe the drug correctly and inform them of contraindications, indications and usage, dosage and administration, warnings and precautions, adverse reactions, drug interactions, use in specific populations, and more. A drug’s label includes what is printed on the bottle’s packing box and the package insert. The label also is also available electronically on the FDA’s website. The electronic label provides the most up-to-date information to health professionals on any changes, such as notice of a new drug interaction. Such access is important because some drugs could sit on a shelf for years, making the paper label outdated.
Making regulatory changes to drug labels is such an important issue that one would think that the FDA would have had discussions with representatives from the brand and generic companies industries, as well as healthcare professionals, to get input before the release of the proposed rule. However, that would be wrong.
After they became aware that a proposed regulation was forthcoming, Reps. Kevin Yoder (R-Kansas), Alan Nunnelee (R-Miss.), and David Valado (R-Calif.) sent a letter on September 20, 2013, to FDA Commissioner Margaret Hamburg expressing concern that the regulation could “expose generic drug makers to expanded and unnecessary tort liability by changing the legal requirements for the labeling of generic drugs” and that “these changes could lead to the undermining [of] a uniform federal standard for drug labeling, and ultimately impact public safety.” They asked the commissioner for the status of the proposed rule change, information on the statutory authority to issue such a change, and a list of any non-governmental parties the commissioner had met with regarding the proposed regulation.
On January 29, 2014, four months after the letter to Commissioner Hamburg and three months after the proposed regulation was released, the congressmen finally received a response from FDA Deputy Commissioner of Operations and Chief Operating Officer Walter Harris. He did not point to any specific statutory authority that would permit the agency to make such a change, but admitted the agency was responding to a citizen’s petition submitted by Public Citizen, a well-known left-leaning public advocacy group founded by Ralph Nader. Harris’s letter also revealed that the FDA’s chief counsel and other FDA officials met with a representative from the American Association for Justice, the trial lawyers’ lobbying and advocacy organization; a representative from a lobbying firm that specializes in food and drug law and torts; and a representative from a law firm specializing in pharmaceutical litigation, to discuss the Mensing case. Harris also claimed that while the FDA “generally does not participate in a dialogue during the development of proposed rules, there are occasions when FDA staff will participate in a listen-only session of interested parties.”
Rep. John Shimkus (R-Ill.) put the incongruity of the meeting more succinctly to FDA Center for Drug Evaluation and Research Director Janet Woodcock during an April 1, 2014 House Energy and Commerce Committee hearing. He asked Dr. Woodcock if the agency had met with anyone representing physicians, pharmacists, and the brand name or generic drug industries prior to writing the rule. She replied that to her knowledge, the agency had not. “So,” said Rep. Shimkus, “you didn’t meet with physicians, you didn’t meet with pharmacists, you didn’t meet with branded drug companies, you did not meet with generic drug companies, but you met with the trial lawyers?”
In November 2014, both the Generic Pharmaceutical Manufacturers (GPhA) and the Pharmaceutical Research and Manufacturers of America offered an alternative to the FDA proposed rule called the Expedited Agency Review (EAR) process. Under the proposal, either a generic or a brand-name company could submit new safety data on a drug to the FDA. If the agency believes a labeling change would be needed, it would have 15 days to inform all manufacturers of its decision. In turn, generic and brand name companies would have 30 days to update their electronic label with the new safety information. Both industries want the FDA to be the final arbiter before any labeling changes are allowed to be updated. After all, only the FDA has all of the information, including proprietary material, submitted by brand name and generic companies concerning a particular drug. Therefore, only the FDA can make a reasonable determination whether a new label is warranted and to mitigate incentives to “over warn.” The GPhA feels so strongly about the proposed rule that it is considering suing the FDA if it is adopted.
The delays in the rulemaking process, which include an extension of the comment period and two missed deadlines for issuing a final rule, have likely been caused by a rift at the FDA between careerists and Obama administration operatives that side with the trial bar. As the trial lawyers and their allies continue to push for the new rule, the generic and brand name companies, along with their supporters, are touting the EAR proposal.
The House Appropriations Subcommittee on Agriculture appears to be listening to the industry’s concerns. During the markup of the fiscal year 2017 Agriculture Appropriations bill, a provision was included to prohibit the FDA from spending any money on the proposed regulation unless it adopts provisions from the industry’s plan.
There is no doubt that the proposed regulation as written would create confusion among health professionals, because multiple labels could exist for the same drug for a period of time. Prescribers would likely avoid prescribing generic drugs due to liability concerns. Simply put, the proposed FDA regulation would be counterintuitive to 30 years of assurance that a brand-name drug and its generic versions are the same. It would create a new level of liability for labels.
FDA has promised a final rule by July 2016. Rather than approving something that will lead to expensive and endless litigation, the agency should reject the proposed rule, continue to promote public safety, and help sustain a vigorous pharmaceutical marketplace that encourages innovation and competition.
