Comments to FDA on Generic Drugs and Industry Proposal

Monday, April 20, 2015

(PDF Version)

Margaret A. Hamburg, M.D. Commissioner
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852


Re: FDA Docket No. FDA-2013-N-0500: Supplemental Comments on Labeling Changes for Approved Drugs and Biological Products

Dear Commissioner Hamburg:

On March 11, 2014, the undersigned organizations submitted comments in strong support of the FDA’s proposed rule regarding “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.”  The comment period has now been reopened.  We strongly reiterate our support for the proposed rule, without modifications.

In our earlier comments, we noted that the proposed rule “properly addresses significant regulatory gaps in the FDA’s current generic drug labeling regulations, which allow a generic drug manufacturer to maintain a label even if it knows that label to be inaccurate and out-of-date.” We noted, “In addition to raising serious safety concerns, the current regulations have had severe legal consequences for patients harmed as a result of unsafe generic drug labels.  See,  PLIVA v Mensing, 131 S. Ct. 2567 (2011).”  

A principal reason we support the rule is that it would allow generic companies to take steps to change label content, “whenever new information becomes available to a generic manufacturer that makes their product’s current label inaccurate,” also known as the “changes being effected” (CBE) process.  This ability is critical for patient safety, ensuring that patients have the most up-to-date product labeling information as soon as possible, regardless of whether they choose a brand-name or generic drug.  What’s more, the rule presents less chance for labeling confusion than existing regulations.  Under current regulations, a brand name drug can already initiate an immediate labeling safety change pending FDA review.  As a result there already are instances where the brand and the generic have different labels for varying lengths of time.  There is currently no requirement for generic labels to be updated within a certain timeframe.  The proposed rule improves upon that regime by requiring that all labels be updated within 30 days after the FDA approves a CBE change.  Overall, the approach set forth in the FDA’s proposed rule will improve the safety of generic drug labels.

The proposed rule would create parity between brand and generic drug companies to independently ensure safe product labels.  However, in a troubling perversion of the “parity” principle, GPHA and PHARMA have joined together to propose an “alternative” rule that would allow both brand and generic companies to escape responsibility to independently fix labels they later find are inaccurate or out-of-date.  The proposal’s title suggests that this provision would take effect after the first generic drug enters the market - typically seven years – even though new safety information often arises years after that.  

Rather than extending the CBE process to generic companies as the FDA’s proposed rule would do, these industries propose abolishing it for brand companies once the first generic drug has entered the market, taking advantage of a fixable generic drug regulatory gap to try to weaken the entire drug safety regulatory regime.  They would replace this process with a scheme they have named “expedited safety review,” which shifts responsibility for safety labeling entirely onto the FDA after generics enter the market.  No longer would manufacturers be permitted promptly to update a safety warning in advance of the FDA’s review of the change, irrespective of the critical safety information that the change may provide.  This result is precisely the opposite of the result sought by the FDA with its proposal rule. 

Irrespective of what time-limits the rule may specify, the FDA has always lacked the resources to act quickly.  As the U.S. Supreme Court said in Wyeth v. Levine, “The FDA has limited resources to monitor the 11,000 drugs on the market and manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge.” In other words, shifting all responsibility for safe labels from manufactures to the FDA, which would be required to act before any label could be changed, is completely untenable and could create a serious risk to public safety.

Moreover, a second insidious consequence would follow from adopting the GPHA and PHARMA proposal.  As the agency is well aware, the triggering event for the FDA proposed rule was the 2011 Supreme Court decision, PLIVA, Inc. v. Mensing.  There, the U.S. Supreme Court immunized the generic drug industry for marketing drugs with labels they know to be unsafe because generic companies cannot independently change drug labels.  This case eliminated important legal rights for patients harmed by unsafe generic drugs – rights that currently exist for consumers of brand drugs.  That right was confirmed by the Supreme Court in Wyeth v. Levine, where the Court refused to preempt state common law in large part because the “changes being effected process” allows brand companies to independently change labels before FDA review. 

There are many ways lawsuits can – and have – led to safety improvements.  In some cases, litigation has caused unsafe and dangerous drugs to be pulled from the market.  Lawsuits also can have a tremendously beneficial role spurring medical research and alerting the public of larger health risks and problems.   In addition, civil cases hold companies directly accountable to those whom they have hurt, and provide injured  patients with compensation to help rebuild their lives.  However, rather than restoring rights to patients injured by generic drugs, the industry alternative would strip away rights for those injured by brand drugs once the first generic drug has entered the market.  These companies would escape liability even if they knew that their products’ labels lacked up-to-date safety warnings – as long as the FDA had not ordered an update.

Under the FDA’s regulatory scheme, primary responsibility for drug safety rests with manufacturers, not the FDA.  The Supreme Court noted in Wyeth v. Levine, that the adequacy of a drug’s label is the “ultimate responsibility” of the manufacturer “at all times.”  The Court wrote,

[T]hrough many amendments to the FDCA and to FDA regulations, it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times. It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market.…

The GPHA/PHARMA proposal would not only undermine this longstanding regulatory principle, ultimately making drugs less safe, it would eliminate the rights of injured patients. The FDA’s proposed rule, in contrast, would make products safer, resulting in fewer injuries and a path to compensation when injuries occur due to failure to warn of known risks.  We strongly support the FDA’s proposed rule and strongly oppose the GPHA and PHARMA alternative.



Alliance for Justice

Center for Justice & Democracy

Connecticut Center for Patient Safety

Mothers Against Medical Error

New Yorkers for Patient & Family Empowerment

Public Justice

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