depakote,birth defect, birth defects,generic, generic drug, granuflo, actos, AVANDIA, BIRTH DEFECT, BIRTH INJURY, FOSAMAX, ANDROGEL, LOW T, RISPERDAL, TRASYLOL, ACCUTANE, ACTOS, DEFECTIVE DRUG, DRUG INJURY, DEFECTIVE DRUG INJURY, YAZ, YASMIN, GIANVI, OCELLA, ZOLOFT, FEN PHEN, PAXIL,DEPAKOTE,topmax, celexa, lexapro, xarelto

Generic Drug Label

This entry was posted in Prescription Drug on by (updated 3621 days ago)

actos, AVANDIA, BIRTH DEFECT, BIRTH INJURY, FOSAMAX, ANDROGEL, LOW T, RISPERDAL, TRASYLOL, ACCUTANE, ACTOS, DEFECTIVE DRUG, DRUG INJURY, DEFECTIVE DRUG INJURY, YAZ, YASMIN, GIANVI, OCELLA, ZOLOFT, FEN PHEN, PAXIL,DEPAKOTE,topmax, celexa, lexaproThe issue related to preemption has surfaced in many courts around the country ( e.g., generic paxil and medtronic infuse bone graft).  And, the FDA is in one the action too.

Recently, the FDA released a proposed rule related to a generic drug label.  The proposed generic drug label rule would possibly bring parity to the world of name brand drug manufacturers and generic drug manufactures.

The FDA in its proposed generic drug label rule is proposing to:

  1. amend its regulations to revise and clarify procedures for application holders of an approved drug or biological product to change the product labeling to reflect certain types of newly acquired information in advance of FDA’s review of the change.
  2. create parity among application holders with respect to such labeling changes by permitting holders of abbreviated new drug applications (ANDAs) to distribute revised product labeling that differs in certain respects, on a temporary basis, from the labeling of its reference listed drug (RLD) upon submission to FDA of a ‘‘changes being effected’’ (CBE–0) supplement.
  3. describe the process by which information regarding a CBE–0 labeling supplement submitted by a new drug application (NDA) holder, an ANDA holder, or a biologics license application (BLA) holder would be made publicly available during FDA’s review of the labeling change and clarifies requirements for all ANDA holders to submit conforming labeling revisions after FDA has taken an action on the NDA or ANDA holder’s CBE–0 labeling supplement.
  4. amend the regulations to allow submission of a CBE–0 labeling supplement for certain changes to the ‘‘Highlights of Prescribing Information’’ for drug products with labeling in the ‘‘Physician Labeling Rule’’ (PLR) format.

As stated on the Federal Register, the alleged non-parity between name brand drug manufacturers and generic drug manufacturers relates to two U.S. Supreme Court cases:

  • “Pliva v. Mensing, the Court held that the difference between NDA (name brand) and ANDA (generic) holders’ ability to independently change product labeling through CBE-0 supplements leads to different outcomes on whether Federal labeling requirements preempt State law failure-to-warn claims”
  • “Wyeth v. Levine, the Court decided that Federal law does not preempt a State law failure-to-warn claim that a brand name drug’s labeling did not contain an adequate warning”

As further stated on the Federal Register, “as a result of the decisions in Wyeth v. Levine and Pliva v. Mensing, an individual can bring a product liability action for failure to warn against an NDA holder, but generally not an ANDA holder, and thus access to the courts is dependent on whether an individual is dispensed a brand name or generic drug.”

The bottom line on the proposed FDA rule related to a generic drug label is that it may help eliminate the federal preemption issue with regard to failure to warn claims in connection with generic drugs.

CFREE CASE REVIEWontact Us

At the Gooch Law Firm, we pride ourselves on providing our clients reliable representation for even the most challenging cases. If you or someone you love has suffered a serious personal injury drug injury in connection with the use of a prescription pharmaceutical drug, contact our office at 1.844.329.5955.

WE ARE HERE TO HELP YOU PROTECT YOUR LEGAL RIGHTS