HEALTH

Op-ed urges reclassification of pseudoephedrine

BY Michael Johnsen

WASHINGTON Former White House drug policy spokesman Robert Weiner and Jonathan Battaglia, a policy analyst at Robert Weiner Associates, on Tuesday released a statement advocating the reclassification of pseudoephedrine as a prescription-only pharmaceutical.

In an op-ed in The State, South Carolina’s largest newspaper, Weiner and Battaglia claimed that Oregon has taken the step and in the three years since 2006 enactment, has cut the methamphetamine crisis in half.

The co-authors suggested that the current federal legislation, the Combat Methamphetamine Epidemic Act, does not go far enough with daily and monthly sales limits for pseudoephedrine.

“The result was a confusing process for retailers and the arrests of law-abiding people with no other motive but getting rid of their cold or allergies,” the two wrote.

The Consumer Healthcare Products Association has been working toward a workable solution that doesn’t entail reclassifying PSE as a nonprescription offering. The association in April officially called on Congress to amend and strengthen the federal Combat Methamphetamine Epidemic Act by requiring nationwide electronic tracking for all over-the-counter sales of cold-and-allergy medicines containing pseudoephedrine.

The proclamation came as the Senate Caucus on International Narcotics Control held a hearing on “The Status of Meth: Oregon’s Experience Making Pseudoephedrine Prescription Only.”

“E-tracking is the only solution that will immediately block illegal sales and prevent criminals from buying illegal amounts of PSE to manufacture methamphetamine,” the CHPA stated. CHPA president Linda Suydam committed on behalf of industry to fund a national system and work with the retail community to expand the National Precursor Log Exchange system currently being implemented in eight states that have passed e-tracking legislation.

The NPLEx e-tracking system works in real time to stop individuals from exceeding package limits when purchasing PSE-containing medicines. Using sales records that retailers are already required to keep and which only are made available to law enforcement, NPLEx works across state lines and provides law enforcement with an effective tool to stop methamphetamine production.

“We are asking Congress to significantly improve the Combat Methamphetamine Epidemic Act by leveraging cutting-edge technology to block illegal pseudoephedrine sales nationwide,” Suydam stated. “Electronic tracking offers the best solution to reducing methamphetamine labs without imposing a costly and unnecessary prescription mandate. Our goal is to stop illegal pseudoephedrine sales while maintaining important over-the-counter access to the 15 million consumers who rely on these medicines each year.”

Ten states already have adopted laws requiring retailers to use an e-tracking system to track PSE sales, CHPA noted, including: Alabama, Arkansas, Illinois, Iowa, Kansas, Kentucky, Louisiana, Missouri, Oklahoma and Washington. Attorneys general from Alabama, Kansas and Washington submitted letters to the caucus noting their support for electronic tracking and urged consideration of e-tracking at the federal level.

CHPA is funding NPLEx in eight of these states to help retailers to comply with these new laws.

Only two states, Oregon and Mississippi, have instead elected to make PSE medicines available by prescription only. Local municipalities within Missouri, but not the entire state, have adopted similar legislation.

Suydam told the caucus that, “when contrasted with electronic tracking, prescription mandates simply fall short. A prescription mandate would be more expensive to consumers, sales limits from [the Combat Meth Act] would no longer apply, and there would be no system for real-time blocking of illegal prescription sales within states or across state lines.”

Suydam also challenged the effectiveness of Oregon’s prescription-only law, noting that most of Oregon’s lab reductions occurred prior to the state’s prescription mandate and that states across the West achieved similar results without such a burdensome restriction.

“The industry supports federal legislation requiring nationwide tracking, and we are asking that the current paper system be modernized to provide a system that will work seamlessly and more effectively across all states,” said Suydam. “E-tracking systems like NPLEx are the most effective tool we have to systematically address methamphetamine production in this country. A multistate approach to electronic pseudoephedrine sales tracking offers more benefits for law enforcement and consumers than a prescription mandate, but without the substantial and unnecessary costs of a prescription approach.”

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AAFA releases ‘Allergy Capitals’ list

BY Michael Johnsen

LANDOVER, Md. The Asthma and Allergy Foundation of America on Thursday released its new list of the 100 “Allergy Capitals” (www.AllergyCapitals.com), naming Knoxville, Tenn. as the most challenging place to live with spring allergies this year due to high pollen counts, high use of allergy medications by patients and too few allergists to treat the burgeoning allergy population.

 

This year, the foundation has teamed up with Lowe’s Home Improvement to educate Americans about the importance of indoor air quality and how a few simple steps can help you reduce your exposure to allergens and irritants at home.

 

 

“Outdoors in spring is tough so some patients think they can stay indoors to remain safe, but you should be just as concerned about indoor air quality,” stated Beth Corn, assistant professor of medicine at the Mount Sinai School of Medicine and past president of the New York Allergy and Asthma Society.

 

 

Experts said that reduction of allergens inside the home is an important part of asthma and allergy prevention, the AAFA stated, especially as Americans spend an estimated $10 billion annually on such household products as vacuum cleaners, air cleaners, bedding, toys and flooring.

 

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FDA to keep a close eye on McNeil operations

BY Michael Johnsen

WASHINGTON According to prepared testimony immediately posted online before members of the Committee on Oversight and Government Reform convened its “Johnson & Johnson Recall of Children’s Tylenol and other Children’s Medicines” hearing Thursday morning, J&J may be under scrutiny for more than the 40 varieties of over-the-counter infant’s and children’s liquid medicines recalled April 30.

“Just last night, the Committee obtained from the [Food and Drug Administration] even more disturbing information,” committee chairman Rep. Edolphus Towns, D-N.Y., stated as part of his opening remarks. “According to an FDA document, McNeil knew there was a potential problem with one of its Motrin products that was on the market in 2008, but rather than issue a public recall, McNeil allegedly sent contractors out to stores to buy the product back and told the stores ‘not to mention’ a recall,” Towns wrote. “After the FDA confronted McNeil about this, McNeil announced a recall of the affected products.”

Regarding the latest recall, Colleen Goggins, J&J worldwide chairman for consumer group, expressed the company’s disappointment in the factors leading up to the recall.

 

“Across our organization, we believe our first responsibility is to the doctors, nurses, and patients, to mothers and fathers, and all others who use our products and services,” Goggins noted has part of her prepared testimony. “In this instance, we have not lived up to that responsibility, and the recall is therefore a disappointment to our chairman Bill Weldon, to me personally, and to the thousands of employees in the Johnson & Johnson family of companies.

 

 

“Johnson & Johnson embraces the work of this Committee, and we hope that today’s hearing will be an important step in furthering public understanding of the recall,” she added, stating that the quality and process issues at McNeil that led to the recall “are unacceptable.”

 

 

Goggins also stressed before the committee that the health risks associated with the recalled products were remote. No serious adverse events associated with recalled products have been reported to date; no raw materials that tested positive for objectionable bacteria were ever used in the manufacture of McNeil’s pediatric products; and McNeil had rejected the products that it found had excess active ingredient before those products reached the supply chain.

 

 

Despite the public apologies issued by J&J, both legislative and regulatory officials have been taking a hard line against the company.

 

 

“Over the last several years, FDA has had growing concerns about the quality of [McNeil Consumer Healthcare’s] manufacturing process,” remarked Joshua Sharfstein, FDA principal deputy commissioner, as part of his prepared remarks. “These concerns have led to a number of unsatisfactory inspections and consumer recalls,” he continued. “FDA has inspected the company’s facilities with an increased frequency, and in February 2010, the agency took the extraordinary step of convening a meeting with the management of the parent company, Johnson & Johnson, to express concern about a pattern of noncompliance.”

 

 

The meeting took place Feb. 19, Sharfstein testified, and included the president of McNeil, J&J’s group chairman and “a number of quality assurance executives from both companies.”

 

 

Sharfstein testified that “FDA requested that senior officials from Johnson & Johnson attend the meeting so they would be on notice regarding FDA’s rising concerns about whether McNeil’s corporate culture supported a robust quality system to ensure the purity, potency and safety of its products.”

 

 

Sharfstein also testified that of all the good manufacturing practices violations the agency identified at McNeil’s Fort Washington, Pa., plant, that the “pubic health risk from these quality problems is low.” The FDA did not find evidence that McNeil used raw materials that tested positive for bacterial contamination. And while there was a potential for higher concentrations of Tylenol per dropper, “none of the final products released for sale tested with high levels [of active ingredient].”

 

 

Going forward, FDA plans to keep a close eye on McNeil operations, Sharfstein testified. What’s more, the FDA will take corporate culture into account in future reviews of any company. “One lesson to be drawn from the McNeil story is that it is important for the Agency to even more fully consider the corporate structure when investigating and enforcing the law,” Sharfstein testified. “[The] FDA will be developing new procedures to use what we learn at one facility in guiding our inspections of other facilities run by the same company.”

 

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