The Consumer Healthcare Products Association said the California Assembly's Public Safety Committee this week failed to pass a bill that aimed to move over-the-counter pseudoephedrine products to prescription status.

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Pseudoephedrine prescription bill fails in California

July 2nd, 2009
Senate Bill 484 aimed to move O-T-C medications with pseudoephedrine to prescription status.

SACRAMENTO, Calif. – The Consumer Healthcare Products Association said the California Assembly's Public Safety Committee this week failed to pass a bill that aimed to move over-the-counter pseudoephedrine products to prescription status.

According to CHPA, the committee vote on Senate Bill 484 came in at 3 yes, 2 no, and 2 present but abstaining. The association noted that although the bill technically could resurface at a later date, it's unlikely to do so.

CHPA said a coalition of the association, its member companies and retailers have waged a lengthy campaign against the proposed legislation, which had strong support from California law enforcement.

Under the bill, consumers would be required to obtain a prescription for O-T-C products containing pseudoephedrine, which includes many popular cold and allergy remedies. Pseudoephedrine is used to make methamphetamine, or "meth," which has ballooned into a major national drug epidemic. In recent years, O-T-C remedies with pseudoephedrine have been moved behind the pharmacy or the checkout counters to help stem methamphetamine abuse.

During the California Assembly hearing, coalition witnesses swayed a majority of the committee to accept a proposal to adopt a statewide electronic tracking system for pseudoephedrine product sales as an alternative to giving the medications prescription status, CHPA explained.

Going forward, the coalition aims to focus on legislation to enable e-tracking of pseudoephedrine products in California and on preparations to deliver such a program, CHPA said.

Those speaking in opposition to the bill included Mandy Hagan and Terri Thomas for CHPA, Trent Smith for Rite Aid Corp., James Gross for the California Pharmacists Association and Kathy Procida for Johnson & Johnson. 

CHPA Comments on FDA Panel Recommendations for Acetaminophen Products

The Consumer Healthcare Products Association has called for improved labeling and more consumer education about over-the-counter medicines containing acetaminophen after a Food and Drug Administration panel this week recommended stronger restrictions on the painkiller's use, citing studies showing that overuse can cause liver damage.

"While we are pleased with the [FDA] committee’s recommendation to allow continued access to O-T-C combination medicines containing acetaminophen, because we know they provide real benefits to consumers, we are disappointed in their divided vote to lower the maximum daily dose and the single dose of 1,000 milligrams of acetaminophen," CHPA president Linda Suydam said in a statement.

Suydam commented that the FDA expert panel made its recommendations based on insufficient data and that there is "overwhelmingly strong data" affirming the efficacy and safety of acetaminophen in its current dosage forms.

"There is universal agreement on the safety of acetaminophen when used as directed on the label. We know that the overwhelming majority of adults use this product safely and that the majority of serious adverse events related to unintentional acetaminophen overdose are associated with prescription medicines containing acetaminophen," she explained.

"In addition to the label, the most effective and most appropriate intervention to address overdose is education," Suydam pointed out. "We support educational efforts to encourage appropriate use of acetaminophen and have already begun developing a comprehensive, research-based education program that includes a consortium of pharmacists, physicians, retailers, the FDA and other health care professionals."

She added that CHPA urges the FDA to add dosing instructions on pediatric products for children ages 6 months to 2 years.

"All of our [member] companies provide dosing instruments with their products. We support the current range of concentrations to easily and safely dose young children," Suydam stated.


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