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FDA Rules May Open Generic Drugmakers to Potential Lawsuits

Rich Smith

Last updated: October 20, 2016 7:29 pm

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Since 2011, generic drugmakers have largely been beyond the reach of injured consumers clamoring for justice through the courts due to the Supreme Court’s 5-4 ruling in Pliva v. Mensing. This ruling found that because generic manufacturers are legally prohibited from initiating label changes without FDA approval, failure to warn claims against generic manufacturers would be preempted by federal law.

That could change if the U.S. Food and Drug Administration (FDA) at last adopts a rule it proposed in 2013. The rule proposes to let generic drug companies update safety information on their product labels without first obtaining FDA approval, even if this safety information submitted by generic drug manufacturers differs from existing brand-name drug labeling. 1

The FDA recently announced that it wants to amend its regulations so that application holders, both generic and brand-name, of an approved drug or biological product can promptly change the product labeling “to reflect certain types of newly acquired information in advance of the FDA’s review of that change.” 2

The FDA said its proposed rule would “create parity among application holders with respect to such labeling changes by permitting holders of abbreviated new drug applications to distribute revised product labeling that differs in certain respects, on a temporary basis, from the labeling of its reference listed drug.” 3

Essentially, generic drug manufacturers who become aware of an emerging safety signal and wish to add such information to their label can do so without first consulting with the FDA, even if this information and labeling do not conform with brand-name labeling.

Currently, generic drugmakers must submit to the FDA any proposed changes to their labels. It can take a month or longer for the FDA to review the submission and approve it before the drug company can begin printing new labels with the updated safety information. 4

Generic Drugmakers May Lose Liability Shield

While the FDA’s rule proposal is hailed in some circles as a boon to consumers, in others it is seen as problematic and a source of concern.

Opponents – and these include the generic drugmakers in particular – fret that the new rule, if implemented, would leave them vulnerable to lawsuits. 5

At present, generic drug companies are generally shielded from lawsuits when a branded drug they’ve duplicated becomes the subject of a tort action. They have enjoyed this protection since the Pliva v. Mensing 2011 U.S. Supreme Court ruling dealing with the preemption of state law by federal law. 6

This ruling has proved problematic for many consumers who have been injured by generic drugs.

Some states require that unless specified by a doctor that only the brand-name drug may be dispensed, a pharmacist is to fill all prescriptions as generic, when available. 7 Other states allow for a pharmacist to dispense a generic as long as a prescriber has not specified that only the brand-name drug must be dispensed.

Many patients do not realize they have been given a generic version of the drug their doctor prescribed until they consult with an attorney regarding an adverse event they have suffered, and are informed of the problematic nature of bringing a successful suit against the generic manufacturer.

The Generic Pharmaceutical Association predicts that the makers of generic drugs could be hit hard with lawsuits if the FDA adopts its proposed rule and the manufacturers don’t update their safety labels with sufficient speed. 8

Let Your Voice Be Heard

The FDA plans to let both sides of the debate give the issue a proper airing during a public meeting later this month in Silver Spring, Maryland.

Meanwhile, the FDA has reopened the comment period for the proposed rule. The agency says you can let it know your thoughts about it. Regardless of how you submit your comments, be sure to include this phrase somewhere at the top of the first page: Docket No. FDA-2013-N-0500.

You can reach them online at http://www.regulations.gov 9 to obtain background documents or read the comments the FDA receives about this issue, just insert that docket number in the “Search” box, then follow the prompts.

If you prefer, you can send a letter to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You can also go in person and ask to see those items.

The FDA says it will accept your comments from now through April 27, 2015.

For more information, contact Ellen Molinaro, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg. 51, Rm. 6218, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. Her phone number is (301) 796-3601.

  1. Robert King, “Controversy Re-Ignites Over Generic Drug Label Changes,” Washington Examiner, February 17, 2015. http://www.washingtonexaminer.com/controversy-re-ignites-over-generic-drug-label-changes/article/2560336. Accessed on March 1, 2015. 

  2. “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” Federal Register, Nov. 13, 2013. https://www.federalregister.gov/articles/2013/11/13/2013-26799/supplemental-applications-proposing-labeling-changes-for-approved-drugs-and-biological-products. Accessed on March 1, 2015. 

  3. “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” Federal Register, Nov. 13, 2013. https://www.federalregister.gov/articles/2013/11/13/2013-26799/supplemental-applications-proposing-labeling-changes-for-approved-drugs-and-biological-products. Accessed on March 1, 2015. 

  4. Robert King, “Controversy Re-Ignites Over Generic Drug Label Changes,” Washington Examiner, February 17, 2015. http://www.washingtonexaminer.com/controversy-re-ignites-over-generic-drug-label-changes/article/2560336. Accessed on March 1, 2015. 

  5. Robert King, “Controversy Re-Ignites Over Generic Drug Label Changes,” Washington Examiner, February 17, 2015. http://www.washingtonexaminer.com/controversy-re-ignites-over-generic-drug-label-changes/article/2560336. Accessed on March 1, 2015. 

  6. Robert King, “Controversy Re-Ignites Over Generic Drug Label Changes,” Washington Examiner, February 17, 2015. http://www.washingtonexaminer.com/controversy-re-ignites-over-generic-drug-label-changes/article/2560336. Accessed on March 1, 2015. 

  7. ASPE Issue Brief: Expanding the Use of Generic Drugs, December 1, 2010 http://aspe.hhs.gov/sp/reports/2010/genericdrugs/ib.shtml#apa. Accessed on March 5, 2015. 

  8. Robert King, “Controversy Re-Ignites Over Generic Drug Label Changes,” Washington Examiner, February 17, 2015. http://www.washingtonexaminer.com/controversy-re-ignites-over-generic-drug-label-changes/article/2560336. Accessed on March 1, 2015. 

  9. “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological
    Products; Public Meeting; Request for Comments; Reopening of the Comment Period,” Federal Register, Feb. 18, 2015, available at http://federalregister.gov/a/2015-03211. Accessed on March 1, 2015.