July 11, 2013

162017_132140396847214_292624_nAs we discussed in our June 27, 2013 blog entitled “U.S. Supreme Court Decision Shields Generic Drug Manufacturers,” the U.S. Supreme Court (“SCOTUS”) held in its 5-4 decision filed on June 24, 2013 that personal injury claims against generic drug manufacturers under design-defect consumer protection state laws that turn on the adequacy of a drug’s warnings are pre-empted by federal law (“we hold that state-law design-defect claims like New Hampshire’s that place a duty on manufacturers to render a drug safer by either altering its composition or altering its labeling are in conflict with federal laws that prohibit manufacturers from unilaterally altering drug composition or labeling”).

The SCOTUS decision overturned a verdict in excess of $21 million in favor of the New Hampshire plaintiff who was provided a generic form of a brand-name drug that caused her to develop an acute case of toxic epidermal necrolysis that caused 60% to 65% of the surface of her body to deteriorate, burn off, or turn into an open wound. She spent months in a medically induced coma, underwent 12 eye surgeries, and was tube-fed for a year. She was permanently and severely disfigured, disabled, and is nearly blind as a result. She alleged that New Hampshire state law required drug manufacturers to ensure that the products they design, manufacture, and sell are not “unreasonably dangerous,” which duty can be satisfied either by changing a drug’s design or by changing its labeling. Since the defendant generic drug manufacturer did not have the option of changing the generic drug’s design because of the provisions of the Federal Food, Drug, and Cosmetic Act (FDCA), the majority opinion of the Supreme Court held that New Hampshire law ultimately required the manufacturer to change the generic drug’s labeling, which federal law precluded it from doing.


The FDA requires brand-name drug manufacturers to advise the FDA when they obtain information regarding adverse reactions to their drugs or when they have new information that the present warning labels regarding their drugs are inadequate. Under such circumstances, the manufacturers of brand-name drugs can seek the FDA’s approval for new warnings and are permitted to advise the public regarding such through what is known as a “changes being effected” supplement before the FDA takes action. Under present regulations, manufacturers of generic drugs cannot issue a “changes being effected” supplement before the FDA formally approves the changes to their warning labels.

The Obama Administration is proposing a federal rule change (which will be formally proposed in September 2013) that would amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA’s review of such change. The proposed rule would describe the process by which information regarding a “changes being effected” (CBE) labeling supplement submitted by an NDA or ANDA holder would be made publicly available during FDA’s review of the labeling change. The proposed rule also would clarify requirements for the NDA holder for the reference listed drug and all ANDA holders to submit conforming labeling revisions after FDA has taken an action on the NDA and/or ANDA holder’s CBE labeling supplement. The proposed revisions to FDA’s regulations would create parity between NDA holders and ANDA holders with respect to submission of CBE labeling supplements.


The proposed rule change would permit both brand-name drug manufacturers and generic drug manufacturers to issue “changes being effected” supplements to drug labels, which would remove the sting of the recent SCOTUS decision, possibly allowing generic drug manufacturers to be held liable if their drugs were unreasonably dangerous and they failed to issue supplemental warnings as permitted by the proposed rule.


The Relevant Portion Of The Present Rule (21CFR314.70):

6) The agency may designate a category of changes for the purpose of providing that, in the case of a change in such category, the holder of an approved application may commence distribution of the drug product involved upon receipt by the agency of a supplement for the change. These changes include, but are not limited to:

(i) Addition to a specification or changes in the methods or controls to provide increased assurance that the drug substance or drug product will have the characteristics of identity, strength, quality, purity, or potency that it purports or is represented to possess;

(ii) A change in the size and/or shape of a container for a nonsterile drug product, except for solid dosage forms, without a change in the labeled amount of drug product or from one container closure system to another;

(iii) Changes in the labeling to reflect newly acquired information, except for changes to the information required in 201.57(a) of this chapter (which must be made under paragraph (b)(2)(v)(C) of this section), to accomplish any of the following:

(A) To add or strengthen a contraindication, warning, precaution, or adverse reaction for which the evidence of a causal association satisfies the standard for inclusion in the labeling under 201.57(c) of this chapter;

(B) To add or strengthen a statement about drug abuse, dependence, psychological effect, or overdosage;

(C) To add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product;

(D) To delete false, misleading, or unsupported indications for use or claims for effectiveness; or

(E) Any labeling change normally requiring a supplement submission and approval prior to distribution of the drug product that FDA specifically requests be submitted under this provision.

(7) If the agency disapproves the supplemental application, it may order the manufacturer to cease distribution of the drug product(s) made with the manufacturing change.


If a defective drug caused injury or other serious harm to you or your family, you should promptly seek the advice of a defective drug claim attorney in your U.S. state who may be able to investigate your bad drug claim for you and represent you in a defective drug claim, if appropriate.

Click here to visit our website or call us toll-free at 800-295-3959 to be connected with defective drug lawyers in your state who may be able to assist your with your bad drug claim.

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