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FDA Defends Generic Drug Labeling Plan

By: Nancy Simon, PharmD c/o 2016

Last November, the Food and Drug Administration (FDA) submitted a proposal for a Generic Drug Labeling Plan.  This new plan will allow generic drug companies to use the same process as the one used by brand drug companies to update their medication labels to reflect new safety information.1 The goal is to give the most updated drug information to the patients who are taking generic medications in a more timely manner. However, the Generic Pharmaceutical Association (GPhA) seems to oppose certain aspects of this plan.

Currently, brand drug manufacturers are required by law to immediately warn doctors and consumers by mail or by updating their product labels when there is clear evidence that a prescription drug has caused harm to patients.  “Federal law does not allow the makers of generics to change the safety warnings on their labels in response to new information until the maker of the branded equivalent has done so, and the change has received approval from the Food and Drug Administration,” states Joe Carlson, a writer at Modern Healthcare magazine.2

Until now, unlike the brand-drug manufacturers, generic drug makers could not update their medication labels until the changes in the brand drug labels were approved by the FDA. Janet Woodcock, Director of the Center for Drug Evaluation and Research at FDA states that “approximately 80 percent of drugs dispensed are generic, and brand drug manufacturers may discontinue marketing after generic drug entry. This involves a process that brand drug manufacturers currently follow,” outlining the reason for this proposal.3

The Generic Drug Labeling Plan would ensure faster dissemination of safety information to the public for both brand-name and generic drugs through medication labeling. Although the FDA acknowledges that there might be a time lapse between labeling changes made by the different manufacturers, the FDA believes generic companies should update their own product labeling as soon as new information is acquired through methods such as post-marketing surveillance.3

Currently, brand drug companies submit new medication labeling using a “CBE-0 supplement”, which stands for changes being effected.3 The brand drug company can update the medication labeling immediately, while the FDA reviews this change. After getting approval from the FDA, the generic drug company can follow suit.3 If passed into law without changes, the proposal will allow generic drug companies to make changes to their drug labeling through the same “process that brand drug manufacturers currently follow.”3

The provision would let generic drug companies submit a CBE-0 supplement on their own while waiting for the FDA to approve the changes, just like brand drug companies.3  In addition, generic drug companies would also be required to provide information that supports the change, which would be promptly forwarded to the brand drug company unless that brand drug has already been withdrawn from the market.3 This would allow the brand drug manufacturer to be immediately notified when the generic drug company makes labeling changes based on important new safety data that emerges for the drug’s generic counterparts.3

The updated safety information can then be sent out to notify prescribers and consumers. The FDA plans on making this information readily available to the public by dedicating a webpage, or modifying an existing FDA webpage, onto which the FDA would post information regarding labeling changes proposed in a CBE-0 supplement.3

This webpage would show pending CBE-0 supplements for safety-related labeling changes, a link to show current labeling for the affected drug product, the approval status of the CBE-0 supplement, and whether the administration has taken action or have determined that the supplement may be irrelevant.3 The CBE-0 supplements would remain available on the webpage until the FDA has fully reviewed them and has issued an action letter.3

If approved, the labeling will also be made available on the proposed webpage.3 This online resource would be a way for brand drug companies to keep track of which generic drug companies are submitting medication labeling updates, and for health care providers and consumers to obtain the most current information about the safety of prescription medications as well.3

The new proposal allows generic drug companies to submit their own medication labeling changes to alert healthcare providers and patients with new safety information, but there may be some disadvantages to this idea as well, according to the GPhA. If this proposal is finalized without changes, generic drug companies will also be subject to “failure-to-warn” claims, which are currently only applicable to brand drug companies and is more than what generic drug companies may be used to.3 Failure-to-warn simply means that the company failed to inform health care providers or consumers of potential hazardous effects of the drugs.

Since brand drug companies have the responsibility to update their medication labels right away, they are held accountable if they fail to warn health care providers, consumers, and the FDA of safety issues such as information on contraindications or adverse effects in a timely manner through changes or additions to drug labeling. For example, “in Pliva v. Mensing, the Supreme Court decided that Federal law does preempt a state law failure-to-warn claim that a generic drug’s labeling did not contain an adequate warning,” which meant that the drug company, Pliva Inc., was not subject to the failure-to-warn claim as a generic manufacturer because the Federal law takes precedence over the state law.3

Ralph Neas, the president of GPhA, stated that the proposal would lead to an increased number of lawsuits against generic drug companies.1 “If the CBE-0 supplement process is made available to makers of generic drugs, as proposed by FDA, those manufacturers would no longer be shielded from these liability claims.”1 Bruce Roberts, a plaintiff attorney, also stated that “once they’ve been given the right to change their label, they get the right to be sued for failing to change their label.”4 It is unclear whether this would be “fair” for the generic drug companies; however, if implemented whether with or without changes, it would make the generic companies another participant in further assuring the safety of consumers.

The FDA’s proposal could also impose significant costs on not only the drug industry, but consumers as well.5 Now that there is more liability involved, generic drug companies would be responsible for knowing the full effects of  their drug products, and this may cause an increase in generic drug prices or a decrease in the number of generic drug manufacturers, according to some.4

Matrix Global Advisors, an economic consulting firm, published a study in February that estimated an annual increase of five percent in generic drug spending.2 Neas stated that the proposed regulation is a “draconian,” or excessively harsh, departure from the trend in lawmaking in the past 30 years.4 He also expressed that generic drug makers are urging FDA to modify the proposal so that the FDA, instead of the generic manufacturers, would be responsible for making the necessary changes to generic drug labeling.4

But this opinion from the president of GPhA—an association of generic manufacturers—should be taken with a grain of salt, because a change to the regulation in this way may also increase the tax-payer’s burden to support the FDA in its venture to improve the patient’s safety in using prescription medications.2

It is true that the prices of brand drugs can be extremely high for patients, and that generic drugs with lower price tags are usually the preferred option by patients. However, this proposal will bring us one step closer to being able to guarantee that the patients who take generic medications are just as shielded from medication safety issues as those who can afford brand name medications.

If this proposal were to pass without changes, generic drug prices may potentially increase.  The FDA proposal would require generic drug manufacturers to make updates to their medication labels and quickly notify health care providers and consumers with crucial safety information. With more power comes more responsibility, which then leads to more liability, which will ultimately lead to higher generic drug costs. On the other hand, if the proposal is passed with changes suggested by the GPhA, the burden on tax-payers may increase.

As healthcare professionals, our goal is to keep the patients safe and healthy. If finalized and correctly implemented, this proposal “is intended to improve the communication of important drug safety information about generic drugs to both prescribers and patients,” said Woodcock.3 However, foreseeing the rise in generic drug prices, it would be interesting to see what implications the decision may have down the line.


  1. Traynor K. FDA Defends Generic Drug Labeling Plan. American Society of Health System Pharmacists Web site. http://www.ashp.org/menu/News/PharmacyNews/NewsArticle.aspx?id=4049. Updated April 28, 2014. Accessed October 30, 2014.
  2. Carlson J. FDA’s generic-drug label rule draws controversy. Modern Healthcare Web site. http://www.modernhealthcare.com/article/20140628/MAGAZINE/306289979. Updated June 28, 2014. Accessed October 30, 2014.
  3. Woodcock J. Examining Concerns Regarding FDA’s Proposed Changes to Generic Drug Labeling. U.S. Food and Drug Administration Web site. http://www.fda.gov/NewsEvents/Testimony/ucm389606.htm. Updated April 1, 2014. Accessed October 30, 2014.
  4. FDA Unilateral Label Change Proposal for Brand and Generic Drug Manufacturers. Medical Research Consultants Web site. http://www.mrchouston.com/fda-unilateral-label-change-proposal-brand-generic-drug-manufacturers/. Updated May 27, 2014. Accessed October 30, 2014.
  5. Karst K. Generic Drug Labeling Preemption: the Flavor of the Day. Hyman, Phelps & McNamara Law Blog. http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2014/03/generic-drug-labeling-preemption-the-flavor-of-the-day.html. Updated March 10, 2014. Accessed October 30, 2014.

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