CRN backs Bayer combination products as functional health supplements
WASHINGTON The Council for Responsible Nutrition last week spoke out against warning letters issued to Bayer Consumer Healthcare by the Food and Drug Administration regarding its dietary supplement/over-the-counter combination products Bayer Aspirin with Heart Advantage and Bayer Women’s Low Dose Aspirin Plus Calcium.
“CRN continues to believe that combination dietary supplement-OTC drug products have a useful and important role to play in integrated health care and wellness,” Steve Mister, president and chief executive officer of CRN said. “Our hope is that the FDA will assist companies attempting to maneuver the regulatory challenges of developing products that combine these ingredients and meet the labeling and formulation requirements of both drugs and dietary supplements, as required by the law.”
CRN noted that the FDA in 1994 stated in the Federal Register that the “FDA does not believe that it would be appropriate to preclude such claims [health claims and OTC drug labeling] under all circumstances. Such claims may be permissible if a firm can demonstrate that dual claims can be made in a manner that will neither misbrand the product nor create a safety problem.” Since then, the FDA has issued a few warning letters addressing specific combinations of supplement and OTC drug ingredients, but has never publicly reversed its view that combination products with dual labeling can be developed that would satisfy the agency’s appropriate concerns for safety.
In its warning letters issued Oct. 28, the FDA charged that the products are unapproved new drugs requiring an approved application for the company to market them. “The FDA considers these products new drugs, and thus, they must undergo the FDA’s drug approval process,” FDA acting associate commissioner for regulatory affairs Mike Chappell said in a statement. “The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process.”
Perrigo may have advantage over patent cliff
ALLEGAN, Mich. Most people know Perrigo Co. as a leading provider of OTC medications and nutritional products, but it also has a sizeable prescription drug business. With the approach of the patent cliff, when the number of blockbuster prescription drugs losing patent protection will decline, some factors may give Perrigo an advantage.
Because Perrigo focuses its prescription drug business on topical medications, vice president for investor relations and communication Arthur Shannon said the complexity of the business insulated it from the effects of the patent cliff.
“The impending patent cliff doesn’t really apply to our business,” he said.
IMS Health vice president for industry relations Doug Long said there could be a competitive advantage for companies that market topical medications.
“I don’t think there is much difference in patent expirations, but the topical market is less competitive than oral solids,” he said. “There are more generic players in oral solids than in topicals probably because topicals are harder to make.”
Shannon also said the company’s OTC business would help it adapt.
“As we look ahead to the foreseeable future, we see good opportunities present for new product opportunities in our OTC business,” he said.
Shannon said the $25 million purchase of Diba, which will add almost $15 million to Perrigo’s annual sales, would make it the leading manufacturer of private-label medicines in Mexico, though Diba also makes prescription drugs, including antibiotics, hormonal and ophthalmic drugs. Perrigo does not plan to market its products in Mexico through Diba, or vice versa.
Nevertheless, that might not be needed.
“We are very comfortable with the future of our generic business,” Shannon said. “Being focused on topicals, we believe we are well-positioned to continue our growth.”
Olympian Michael Phelps launches PureSport athletic drinks
CHICAGO Michael Phelps, winner of eight gold medals during this year’s summer Olympics, officially launched his PureSport brand of performance beverages here on Saturday.
PureSport features an optimal carbohydrate-to-protein ratio of 2:67-to-1 that was created by University of Texas’ John Ivy. The two PureSport formulations include, PureSport Workout, which is used prior to and during exercise to improve endurance and reduce muscle tissue damage, and PureSport Recovery, which is used within 30 minutes of completing a workout to speed the storage of muscle and liver glycogen and promote muscle tissue repair.
More than 1,500 fans turned out to meet Phelps and learn more about the sports beverage that was a big part of his success, according to Phelps.
Among the athletes who have incorporated PureSport into their training regimens are world-class swimmers Michael Phelps, Brendan Hansen, Ian Crocker and Aaron Peirsol, as well as Gold medal gymnast, Nastia Liukin.