NACDS supports Senate move to delay bidding program; bill’s sponsor warns of the cost
ALEXANDRIA , Va. The National Association of Chain Drug Stores released a statement today praising the introduction of legislation in the Senate that will delay and reform Medicare’s competitive bidding program for durable medical equipment, prosthetics, orthotics and supplies.
The Medicare DMEPOS Competitive Acquisition Reform Act of 2008 (S. 3144), the Senate’s companion bill to last week’s H.R. 6252 of the same name, was introduced by Senate Finance Committee chairman, Max Baucus, D-Mont., and ranking member of the committee Charles Grassley, R-Iowa.
According to NACDS, the Centers for Medicare and Medicaid Services has excluded diabetic supplies sold at retail pharmacies from the competitive bidding program in part because of the unique nature of this disease and its impact on beneficiaries. While providing meaningful safeguards and enhancement to the program, the sponsors of the bill rejected harmful proposals to freeze and/or cut the fee schedule for these products or expand competitive bidding to include diabetic products sold at retail pharmacies.
In a letter to the bill’s sponsors, NACDS declared its strong support for the Medicare DMEPOS Competitive Acquisition Reform Act. “We thank Chairman Baucus, Ranking Member Grassley, and Senators Debbie Stabenow, D-Mich, and George Voinovich, R-Ohio, for siding with Medicare beneficiaries and recognizing that interaction with pharmacists is critical in proper diabetes management,” said NACDS president and chief executive officer Steve Anderson. “The Senate bill will help to ensure that suppliers are treated more fairly and that beneficiaries continue to have access to necessary items and services.”
House Ways and Means Health Subcommittee chairman Pete Stark, D-Calif., who sponsored the House bill alongside Health Subcommittee ranking member Dave Camp, R-Mich., warned that the delay does not come without a cost, however. The legislator estimates that the bill’s 18-month delay, which the DME industry would have to finance, could wind up increasing Medicare spending by $3.1 billion over five years.
“The Bush administration designed this program with blinders on to the needs of … the small companies that make up most of the DME industry,” Stark said, according to reports. “But as I told the industry from the start, this is no free lunch.”
Major drug companies agree to six-month moratorium on DTC ads
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.
FDA grants Mylan approval for generic Avalide application
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.