Regulatory Focus™ > News Articles > House Legislators Gear Up to Directly Challenge FDA's Generic Drug Labeling Rule

House Legislators Gear Up to Directly Challenge FDA's Generic Drug Labeling Rule

Posted 25 February 2014 | By Alexander Gaffney, RAC

House legislators will soon hold a hearing on their and industry's "concerns" about the US Food and Drug Administration's (FDA) recent proposal to change the way generic drug labels are updated in light of new and emerging safety risks.

Background: The Rule

In November 2013, FDA proposed to allow generic drug manufacturers to temporarily update their labels if they were made aware of new safety issues that might pose a risk for consumers. Those updates, which would be done through the submission of a Changes Being Effected (CBE) Zero-day (CBE-0) application, would allow the companies to immediately make changes while waiting for FDA and the owner (if they still existed) of the original reference listed drug (RLD) to decide if the change was necessary.

FDA's intent, it said, was to permit differences to exist between the NDA and the ANDA on a "temporary basis."

ANDA holders would need to send the NDA holder both the labeling change and a copy of the information supporting the change.  This requirement is waived if the original NDA has been withdrawn, but would otherwise "ensure that the NDA holder for the RLD is promptly advised of the newly acquired information that was considered to warrant the labeling change."

Any changes would affect both the generic and RLD owners' labeling, FDA said.

Generic drug manufacturers would also be able to distribute "Dear Health Care Provider" letters.

Background: Criticism

With the exception of support from some public interest groups and Democratic legislators, the response to FDA's proposed rule has been almost uniformly negative.

The rule was almost immediately slammed as being likely illegal by a number of leading legal experts. The generic drug industry said the rule would likely cost it-and consumers-billions in additional legal costs each year, and also raised concerns about the proposal's legality. Branded drug companies said the rule could fuel lawsuits against their products.

And in January 2014, a Republican group of House and Senate legislators wrote to FDA saying that the rule "would conflict directly with the [generic drug] statute, thwart the law's purposes and objectives, and impose significant costs on the drug industry and healthcare consumers."

"It is important that we fully understand how FDA came to this decision and what impact the agency believes such an approach would have on patients and providers," said Fred Upton, chairman of the House Energy and Commerce Committee. "For years, the 'sameness' requirements have made it easier for both patients and providers to understand the benefits and risks, providing peace of mind and encouraging competition in the generic drug market. The proposed changes by FDA raise a number of concerns and potentially significant costs that FDA needs to explain to Congress and the American people."

The letter went on to list 11 questions which seem geared toward calling into question both the appropriateness and need of FDA's proposed rule. For example, legislators asked if FDA had considered alternatives or had considered the impact of the rule on various types of drugs. Legislators also seemed skeptical about FDA's cost estimates of the program, which FDA pegged at between $4,237 and $25,852. "No explanation is given as to how the FDA derived such a low estimate," the legislators wrote.

Direct Challenge

Now FDA is gearing up for the most direct challenge to its proposal yet. On 24 February 2013, the House Energy and Commerce Committee's Subcommittee on Health issued a notice that it will soon hold a hearing on the proposed rule.

While neither the details nor the witnesses of the hearing have yet been made public, its title, "Examining Concerns Regarding FDA's Proposed Changes to Generic Drug Labeling," implies that it will focus on the problems of the law.

And the hearing's sponsor, Chairman Pitts, was a signatory of the January 2014 letter to Commissioner Hamburg, implying that those problems will receive ample attention at the meeting.

While the hearing may well include top FDA officials like Hamburg, it's also likely to include the top FDA official in the Office of Generic Drugs (OGD), Kathleen Uhl, who only assumed the title of acting director in March 2013 after the previous director abruptly resigned. Uhl has worked at FDA for more than 15 years, according to the agency.

Additional details about the hearing will likely be made available in advance of the 3 March 2013 meeting.


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