OverTheCounterToday

Sharfstein Is Acting FDA Commissioner As Hamburg Awaits Confirmation

Josh Sharfstein will begin his FDA career March 30, serving as acting commissioner while awaiting the confirmation of President Obama's nominee for the spot, Margaret Hamburg.

Parliament Passes Updated Cosmetics Directive For All 27 European States

The European Parliament has modernized cosmetics oversight by replacing the national laws of its 27 member-countries with a single regulation.

Judge Orders FDA To Reconsider Plan B Distribution Restrictions

A federal judge has ordered FDA to allow nonprescription sales of the Plan B emergency contraceptive to 17 year olds and to reconsider whether to make the drug available to women of all ages without a prescription.

 

Judge Edward R. Korman’s March 23 ruling could draw the Obama administration and the FDA leadership into either defending one of the agency’s most contentious decisions under the Bush administration, or agreeing to ease restrictions on access to the emergency contraceptive, commonly called the “morning after pill.”

 

Questions on how the agency will respond could surface in Senate confirmation hearings for Health and Human Services Secretary-designate Kathleen Sebelius, who has already drawn some criticism for abortion-related policies she addressed as Kansas governor. Comments on the agency’s response to this court order could also mark FDA Commissioner-designate Margaret “Peggy” Hamburg’s confirmation proceedings.

 

Ruling in the U.S. District Court for the Eastern District of New York, Korman ordered FDA to rescind the limit on nonprescription Plan B access to women 18 years old and over because “no useful purpose would be served by continuing” to require that 17 year olds have prescriptions for the drug.

 

FDA must comply with the order within 30 days if it does not appeal and seek a stay of Korman’s order.

The ruling highly critical of FDA attrracted coverage across the country, such as this Washington Post article, and outside the U.S. as well, including this Euronews 24 item.  

 

Korman said the requirement that Plan B be distributed only by pharmacists can continue. FDA's Center for Drug Evaluation and Research said it is reviewing the ruling.

 

The judge criticized FDA's handling of Barr Pharmaceuticals' switch application for Plan B (levonorgestrel). The agency's actions that led to the dual-status distribution "were arbitrary and capricious because they were not the result of reasoned and good faith agency decision-making," he said.

 

FDA approved a Plan B switch under a unique dual-status scheme in August 2006 after Barr, which has since been acquired by Teva Pharmaceuticals, offered to conduct a tracking program to determine whether stores comply with the age restriction.

 

However, critics of FDA argued the dual-status designation was orchestrated to appease Capitol Hill interests and facilitate former Commissioner Andrew von Eschenbach's confirmation to the post.

Waxman Wants Separate Food Agency Off The Table - For Now

 

House Energy and Commerce Committee Chairman Henry Waxman does not back establishing a separate food safety agency before enacting legislation to strengthen FDA's current authorities.

Where There's Smoke, There's An NRT Market

 

 

Tobacco may be good for the pharma sector's health.

 

GlaxoSmithKline Consumer Healthcare is capitalizing on growing anti-smoking sentiment with plans to introduce its smoking-cessation products in more markets worldwide. Glaxo plans to launch its OTC and Rx nicotine-replacement therapy products in India, China and Russia among other markets, the firm announced at the World Conference on Tobacco OR Health in India.

 

Glaxo hopes to make NicoDerm CQ, Commit, NiQuitin and Nicabate available to 85 percent of consumers worldwide by 2013. GSK plans a marketing push in countries where it does not yet sell its NRTs, the Wall Street Journal reports. According to the firm, a World Health Organization report found that tobacco use was increasing most rapidly in low-income countries due to steady population growth coupled with tobacco industry efforts.

 

Meanwhile, the Obama administration and congressional leaders are pushing legislation to give U.S. health regulators authority over tobacco products. The Tan Sheet takes a look at what this might mean for FDA's health here (Available to subscribers only. Get a free trial here.).

And our colleagues at the RPM Report discuss here how attention on tobacco as the bigger bad guy in the health care reform effort allows big pharma to breathe a little easier.

 

 

Recession Left Off Expo West Guest List

We don't know if attendees were hitting the free samples of St. John's wort too often, but the biggest economic news out of the weekend’s Natural Products Expo West was perhaps the lack of big economic news. For this industry, at least.

Patrick Rea, publisher of Nutrition Business Journal, kicked the conference off by urging attendees to “get into the natural products industry bubble” at the Anaheim, Calif., show, where exhibitor and attendance numbers were “in-line with what it was last year.”

“We’re deciding we don’t want to participate in the downturn,” said Enzymatic Therapy CEO Randy Rose. Although he admitted the natural medicine and supplement company’s business has “been pulsing slightly differently” than a year ago due to slowing retail foot traffic, sales remain strong. Rose added that he noted “a buoyant mood” among retailers at the expo, especially compared to what he saw last October at Expo East in Boston.

Ron Fugate, president and CEO of Alacer Corp., touted the “strong growth in consumption” of his firm’s vitamin drink mix Emergen-C – a product he excitedly pointed out was used by Barack Obama on the campaign bus. To attract non-presidential consumers, Fugate said Alacer does well in converting consumer samples – about 10 million each year – to sales, and is continuing to innovate with new stock-keeping units, including a forthcoming energy shot product.

Another big winner, not surprisingly, seemed to be private-label manufacturers. Gus Barni, president of Atlas Operations in Pompano Beach, Fla., said his firm saw a boost in business of almost 15 percent in 2008, and is projecting “somewhere between 30 and 50 percent” growth in 2009. Barni, whose facility manufactures supplements, herbal formulas and nutraceuticals, called the recession “a tremendous opportunity” for companies with solid science behind their ingredients.

East Meets Expo West

Even in the darkest of economic times, China shines as a growing and ever-more welcoming market for dietary supplements and other natural products, says Jeff Crowther, head of the Natural Products Association’s Beijing office.

On the first day of the Natural Products Expo West convention in Anaheim, Calif., Crowther spoke on the market potential for supplements in China, citing an economy still growing 8 to 9 percent each year, a middle class roughly equal in size to the entire U.S. population, an estimated 260 million people over the age of 60 by the year 2025 and a persistent desire for U.S. products.

Unlike in many other nations, Crowther explained, China’s densely packed populace and highly developed social networks make it a prime market for direct selling of supplements – more than 50 percent of its estimated $6 billion in natural products sales are made this way.

Additionally, Crowther said a new food safety law finalized at the end of February may make life easier for firms seeking to register health foods in China – currently a highly bureaucratic regulatory process that can cost a foreign firm more than $20,000 per stock-keeping unit and often includes an 18-24 month waiting period prior to approval. Crowther said the law, slated to go into effect in June, hints that some health food registration fees may be removed. He added that his office plans to meet with China’s State Food and Drug Administration to clarify potential loopholes or gray areas in the law.

Lest he paint too rosy a picture of the Chinese supplement market, Crowther also emphasized the need for a “look before you leap” approach in entering a foreign industry whose adherence to good manufacturing practices and supply chain maintenance can best be described as a work in progress.

Capitol Hill Touts GAO Report, Plans Tighter Regulation Of Supplements

Influential members of Congress say they have proof in a Government Accountability Office report for providing FDA with additional authority to regulate dietary supplements.

In the March 2 report requested by the House Energy and Commerce Committee on FDA’s regulation of supplements and functional foods, GAO recommends the agency “request additional authority to oversee dietary supplements.”