Democrats are seeking to significantly increase FDA authority over over-the-counter drug monographs and potentially change the face of OTC advertising, prompted by recent high-profile concerns over pediatric cough/cold medications.

The Non-Prescription Drug Modernization Act, introduced Nov. 6, would give FDA authority to quickly amend or repeal OTC drug monographs without being required to pursue notice and comment rulemaking as currently mandated under the Administrative Procedures Act.

NPDMA also would subject OTC drug advertising to certain provisions and regulations currently applied to prescription drug direct-to-consumer advertising, including some elements of the recently passed FDA Amendments Act of 2007.

Reps. Henry Waxman, D-Calif., and Tom Allen, D-Maine, and Sen. Ted Kennedy, D-Mass., say H.R. 4083/S. 2311 "would give FDA the authority to act quickly to protect consumers from unsafe or ineffective OTC drugs, by allowing the agency to revoke authorization to market such drugs without a lengthy rulemaking."

Under NPDMA, FDA could expedite changes when it identifies a monograph it believes should be amended because a drug may pose a significant risk, or finds - following an advisory committee meeting - that a monographed drug lacks evidence of effectiveness.

After any change, FDA "may provide a period for public comments on the amendment or repeal and may make additional changes with respect to the monograph to reflect comments received, if determined appropriate by the [HHS] Secretary," the bill says.

However, the agency would not be required to offer such a comment period.

Over-the-counter drug firms are likely to take issue with some of the authorities NPDMA would give FDA, as the bill is currently constructed.

The Consumer Healthcare Products Association is still in the process of reviewing NPDMA and consulting with members, but suggests the monograph authority in the bill may not provide an adequate role for scientific evaluation.

"We feel that any process to reevaluate data is best addressed through a clearly defined and transparent process, and we fully support efforts to achieve this goal in a more streamlined fashion," CHPA told "The Tan Sheet."

"Any attempt, however, to expedite the current regulatory authority should continue to ensure an opportunity to bring all the best science to the discussion," the group said. "We are committed to ensuring that the best science is applied to all of our medicines."

Advertising Authority Shift

Another major element of the Waxman/Kennedy bill would give FDA authority over OTC drug advertising, currently under the purview of the Federal Trade Commission.

"Unlike the FDA, FTC is not a public health agency with scientific expertise - it is strictly a law enforcement agency and its enforcement activity in the area of OTC drugs has been minimal," the sponsors said. "In fact, FTC's most recent enforcement action against an OTC drug advertisement was in 1996."

CHPA says transferring authority over advertising "to an already overburdened FDA is unnecessary." The industry is already subject to "strict standards from the federal government to assure that all OTC advertising is truthful and not misleading," the group says.

Failure to comply with these current standards makes firms "subject to the scrutiny of not only the U.S. Federal Trade Commission, but other third party entities as well," including the business community, nongovernmental third parties and private rights of action, CHPA adds.

OTC Ad Rules Would Conform To FDAAA

Under NPDMA, civil monetary penalties for direct-to-consumer prescription drug advertising violations - recently established under the FDAAA - would apply to OTC drug advertisements as well.

Under FDAAA amendments to the Food Drug and Cosmetic Act, the agency can fine companies for false and misleading DTC prescription drug ads, up to $250,000 for the first violation and $500,000 for subsequent violations in any three-year period.

Language in the Waxman/Kennedy bill would extend the penalty authority to OTC drugs.

But another Waxman/Kennedy provision could lead to OTC drug advertising that more closely resembles prescription drug advertising.

OTC drugs would be placed under provisions of FDCA, section 502(n), which says an Rx drug is misbranded unless "all advertisements and other descriptive printed matter" distributed with respect to a drug include its "established name," the formula "showing quantitatively each ingredient of the drug" and other information relating to side effects, contraindications and effectiveness.

NPDMA also would require FDA to revise regulations mandated under 502(n) in order to include OTC drugs.

The bill includes a "transitional provision" designed to enact this misbranding for false advertising immediately, until revised regulations under 502(n) kick in.

The 502(n) misbranding provisions were recently amended by FDAAA to require TV and radio ads to communicate side effect and contraindication information "in a clear, conspicuous and neutral manner." This requirement would also apply to OTC drugs if Waxman/Kennedy passes in its current form.

Another FDAAA amendment to FDCA that would be extended to OTCs under Waxman/Kennedy requires print ads to carry a MedWatch toll-free number for reporting adverse events.

Monograph System Shakeout

NPDMA also would require FDA to solicit public comment to identify potential changes to monographs.

Specifically, FDA would have to open a docket to receive comments from the public, including medical societies, scientists and other experts, "to gather their views on any changes or updates that should be made to products regulated under FDA's current monograph system," the sponsors note.

The agency would be required to file a report with Congress after the comment period closes, but within two years of the bill's enactment.

The report would include a list of monographs that should be amended and "an assessment of the resources FDA would need to conduct such a review and make any necessary changes to the monographs."

OTC Critics Back Bill

The Non-Prescription Drug Modernization Act arrives amid heightened attention to OTC drugs in the media and on Capitol Hill.

Recommendations made by a recent FDA joint advisory panel to ban certain OTC cold medicines for children under age 6 prompted the bill, according to Waxman (¹ Also see "FDA Panel Narrowly Votes Against Cough/Cold Drugs For Children Up To Age 6" - Pink Sheet, 22 October, 2007., p. 3).

Waxman has also pushed for an FDA advisory panel to review efficacy of the decongestant phenylephrine, which is now slated for a December meeting (² [A#05150440005], p. 8).

University of Florida pharmacy professor Leslie Hendeles, who petitioned for the phenylephrine review and says FDA should scrutinize other OTCs, supports NPDMA. The bill would "provide FDA with the power to more effectively regulate OTC drug products than under the current, 30-year antiquated monograph system," he says.

FDA "would then be able to turn their attention to OTC antihistamines that pose a greater risk of adverse effects than prescription antihistamines, as well as expectorants and cough suppressants that are no more effective than placebo at FDA-approved doses," he told "The Tan Sheet."

The Consumers Union, publisher of Consumer Reports, commended the bill in a Nov. 7 letter to Kennedy, the Senate Health Committee chairman. The bill will be a "major help to consumers in better identifying over-the-counter medicines that actually work and eliminating OTC drugs that may be dangerous," the consumer group says.

The result would be "substantial dollar savings for consumers and improved safety for America's families," Consumers Union says. "We need an FDA that can require quick OTC removal when there is evidence of harm and no evidence of benefit."

H.R. 4083 was referred to the Committee on Energy and Commerce, and S. 2311 was sent to the Health, Education, Labor, and Pensions Committee.

- Christopher Walker (c.walker@elsevier.com)

Waxman Bill Would Alter OTC Ad Rules, Streamline FDA Monograph Authority

More from Archive

More from Pink Sheet