Generic Drug Full Disclosure – A Solution To The Supreme Court’s Decision In Bartlett
By: Stuart Scott
Last fall, the Food and Drug Administration (FDA) announced a proposed rule that would change how and when generic drug companies need to update their warning labels. The Federal Food, Drug and Cosmetic Act (FDCA) requires that generic drugs must have the same approved label as the brand-name drug (known as the Reference Listed Drug, or RLD). It has been the position of the FDA that this same “labeling” requirement applies throughout the life of the drug. But the FDA proposed rule would change that by allowing generic drug companies to substantively update their drugs’ labeling, without waiting for the RLD’s labeling to be updated first, to reflect newly acquired information about the drug. This change would make generic drug manufacturers responsible for monitoring the health effects of their drugs and changing labels to reflect new dangers or an increased risk of known dangers. Under the proposed rule, a generic maker’s legal liability for failure to promptly update its drug label with adequate information warning doctors and patients about the risks and dangers of its drug would no longer be shielded by federal preemption – currently afforded the industry by the Supreme Court’s recent landmark decisions in PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011) and Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013).
The Process Of Drug Labeling
Presently, when a drug is approved by the FDA, whether a brand name or generic, the manufacturer may make changes to the FDA-approved labeling through three different types of submissions:
1. Prior Approval Supplement
2. A Changes-Being-Effected Supplement (CBE)
3. Annual Report
Changes submitted via a Prior Approval Supplement cannot be implemented until the FDA approves the changes. Changes submitted via a CBE can be implemented by the drug maker upon the FDA’s receipt of the supplement. (FDA still ultimately reviews and approves or rejects the proposed changes). An RLD’s labeling must be updated through the submission of a CBE to reflect newly acquired information about the clinical hazards of the drug in the form of a new or more robust warning. The labeling must be updated as soon as there is reasonable evidence of causal association. Because of the “same labeling” requirement the CBE process is only available for generic drugs when the label is being updated for the RLD. In other words, a generic drug maker cannot independently update its drug labeling to add or strengthen a warning regardless of the evidence of risk or hazard unless and until the FDA approves an update to the RLD’s labeling. It is from this regulatory framework and the capitulation of a majority of Supreme Court Justices that the generic drug industry has been able to forge the nearly impregnable defense of federal preemption against failure to warn tort claims.
It is not uncommon for injury victims to need time off from work. Unfortunately, there is no easy answer to the question of whether their employer is required to allow them to take a medical leave. The Family and Medical Leave Act, 29 U.S.C. 2601 et seq. (“FMLA”), the Americans with Disabilities Act, as Amended, 42 U.S.C. 12101 et seq. (“ADAAA,” formerly known as the “ADA”), and its Ohio counterpart, R.C. §4112.02, all require some employers to allow some employees to take medical leave. There is a tremendous body of case law and administrative regulations interpreting these statutes. This article is intended only to provide a brief overview of the law regarding medical leaves in the employment context.
To determine whether an employee is entitled to take a medical leave, the first step is typically to determine whether the FMLA applies. If the answer to any of the following questions is “no,” then the FMLA will not apply to your client:
Did the employer have 50 or more employees for at least 20 workweeks in the current or preceding calendar year?
Has your client been employed for at least one year with that employer?
Has your client worked at least 1,250 hours for that employer during the past 12 month period?
If the answer to all of these questions is yes, then the client is entitled to take up to twelve weeks of leave per year for his or her own serious medical condition. FMLA leave is typically unpaid, but the employer must continue to provide benefits. The employer may require the employee to use up accrued vacation and personal days as part of the 12 week period. The use of paid leave does not extend the leave.