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The way drugmakers handle demands for price breaks from large-volume purchasers over the next two years will help determine whether those price concessions will be taken into account when setting reimbursement formulas under the new Medicare Rx law.
Drugmakers not only support a recent move by a major accreditor of continuing medical education (CME) providers to ensure that scientific experts aren’t excluded from CME programs based solely on their connections to pharma firms, but add they would like to see conflict of interest rules applied equally to nonprofit CME sponsors, according to an official at PhRMA.
The European Parliament last month voted to give brand firms up to 11 years of exclusivity on products before they would have to face generic competition, a move that European generic drug advocates say could delay generic entry but will also provide for a more efficient regulatory system.
The FDA’s anticounterfeiting initiative and the growing trend of drugmakers’ exerting control over their distribution chains should get a boost from model state rules being developed to beef up oversight of drug wholesale distributors.
With the reimbursement rates for Medicare-covered drugs having changed at the beginning of the year in response to the Medicare prescription drug benefit law, drugmakers
In order for law enforcement officials to have access to older drugmaker records, the Centers for Medicare & Medicaid Services (CMS) has extended recordkeeping requirements for Medicaid-covered drugs from three years to a full decade.
Pharmaceutical firms must now inform federal antitrust watchdogs when they settle disputes over the launch of generic versions of brand drugs. The Federal Trade Commission (FTC) yesterday published a reminder to drugmakers that they have only 10 business days after reaching an agreement to file a copy with the commission and the Justice Department.