PHARMACY

AMA backs policy banning tobacco sales in stores with clinics

BY Antoinette Alexander

CHICAGO Physicians are backing a new public health policy that bans the sale of tobacco products and/or byproducts in retail outlets housing store-based health clinics.

The American Medical Association voted to adopt the policy at its Annual Meeting in Chicago on Tuesday.

“It’s ridiculous for stores that house health clinics to sell tobacco products,” stated AMA board member William Dolan, M.D. “To keep the objective of getting and keeping patients healthy, the sale of tobacco products must be banned from any health care facility.”

Additional policies that were voted on during the AMA’s policy-making meeting in Chicago include a rating system for processed foods, opposition to the addition of flavors to cigarettes and elder mistreatment.

The policy that bans the sale of tobacco products in those retail outlets that have an in-store health clinic was brought forth because several states, including Illinois, are looking to pass such legislation. Having the AMA’s blessing could help those states in their pursuit.

“We do not understand how forcing retailers to choose between having an in-store clinic and selling tobacco products serves the broader goal of providing consumers with easier access to high-quality, affordable healthcare. The Federal Trade Commission was clear in its recent opinion regarding retail clinics about the importance of creating an open and competitive healthcare marketplace. Their opinion further reinforced anti-competitive regulations—like those that the AMA is suggesting— would not, in fact, be in the public interest. The Convenient Care Association fully agrees with the FTC’s position,” stated Tine Hansen-Turton, executive director of the CCA. “The CCA remains committed to educating the medical community and decision-makers on the important role retail-based health clinics can play in creating access to affordable healthcare. We look forward to continuing open dialogue with the AMA on the issues of real importance to healthcare consumers: quality, access, affordability, and convenience.”

As previously reported by Drug Store News, the Federal Trade Commission recently approved staff comments regarding proposed regulation of retail health care facilities in Illinois. Among the concerns is the bill’s (HB 5372) prohibition on the location of a clinic “in any store or place that provides alcohol or tobacco products for sale to the public.”

As to HB 5372’s tobacco and alcohol sales restrictions, FTC staff recognized the state’s interest in safeguarding the health and welfare of citizens and that such interests may prompt regulatory restrictions that guard against, for example, the sale of alcohol and tobacco products to minors. However, the rationale for not allowing a clinic in a retail store that also sells tobacco or alcohol is unclear, according to the FTC. At the same time, this restriction could limit the supply of retail clinics and the basic medical services they would provide if retail stores were to decide sales of tobacco and alcohol were more profitable than having a retail health clinic.

Responding to the AMA’s adoption of the new health policy, Walgreens, which owns Take Care Health Systems, issued a statement that read, “Access to health care is limited when regulations focus on products sold by the retailer. Take Care Health Providers can be an effective resource for those trying to quit smoking by offering information on smoking cessation programs and healthy lifestyles, and referring them to products available at the store. Retail health clinics shouldn’t be singled out among other health care facilities that can educate patients on the benefits of not smoking.”

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Major drug companies agree to six-month moratorium on DTC ads

BY Drew Buono

WASHINGTON Under pressure from some of the top members of the House of Representatives, top drug companies, including Merck, Johnson & Johnson and Pfizer, are agreeing on a six-month moratorium on advertising new drugs to consumers and will limit how doctors are used in their ads, according to reports.

The changes were unveiled in letters the manufacturers sent the House Energy and Commerce Committee responding to a request from committee chairman John Dingell, D-Mich., and Rep. Bart Stupak, D-Mich., who head the committee’s oversight and investigations panel.

Dingell and Stupak had wanted the companies to impose a two-year voluntary moratorium on advertising of new prescription drugs to consumers – and possibly even longer in the case of drugs for which not all studies have been completed. The lawmakers also asked the drug companies to limit the use of doctors in their advertising and agree to “black box” warnings on ads if the Food and Drug Administration requested them.

In the letters, executives of J&J, Merck, Merck/Schering-Plough and Pfizer agreed to take several steps, while the Pharmaceutical Research and Manufacturers of America agreed to hold further meetings with the committee. The companies will start following the American Medical Association’s guidelines about using actors to portray doctors, and at least one marketer, J&J, said it would not use doctors in ads to discuss the benefits of a drug.

The drug companies said in their letters that the six-month moratorium formalized industry practice, which is to educate doctors before moving to consumer communications. “We drugs [that] requires that our operating companies spend at least six months after approval have adopted internal guiding practices on direct-to-consumer advertising for prescription of a new medicine educating health professionals before commencing a direct-to-consumer advertising campaign,” wrote William Weldon, chairman and chief executive officer of J&J. He added that the company “does not believe a particular fixed period of time for an advertising moratorium is appropriate in all circumstances.”

Dingell and Stupak said they were pleased with the response, but wanted the drug companies to go further, with a two-year limit.

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FDA grants Mylan approval for generic Avalide application

BY Alaric DeArment

PITTSBURGH The Food and Drug Administration has granted tentative approval to Mylan Pharmaceuticals for its application for a generic version of Sanofi Aventis’ Avalide Tablets.

The tablets, generically known as irbesartan and hydrochlorothiazide, are used to treat hypertension. The application is among the 92 that Mylan has submitted to the FDA for approval.

Avalide had U.S. sales of about $288 million for the 12 months ended March 31, according to IMS Health.

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