FDA proposes rules for conflict of interest disclosure for committee members
WASHINGTON The Food and Drug Administration has announced proposed rules that will reduce the potential conflicts of interest among outside experts who advise the government on the approval of drugs and other regulated products, according to washingtonpost.com.
Experts on the advisory committees would have to fill out a form disclosing the potential conflicts and explaining why they should still be able to advise the agency. If the FDA agrees to a waiver, the disclosure form would be posted on the FDA’s website for at least 15 days before the committee meets.
The goal now is to have that process “conducted in an open, transparent way so people will have confidence and the appropriate trust,” the FDA’s commissioner, Dr. Andrew von Eschenbach, told reporters.
Under the current system, outside advisers inform the FDA of potential conflicts. The agency may grant a waiver if it is deemed in the best interest of the advisory process to have the expert’s input. The FDA then announces when waivers are granted but does not routinely release the disclosure documents.
The proposed rules will be open for public comment for 60 days before the FDA makes a decision whether to revise or adopt them.
Walgreens offers customers free help with Medicare plans
DEERFIELD, Ill. Today marks the beginning of the open enrollment for Medicare Part D plans. It will last from now until Dec. 31 and will allow seniors to pick which plan will be best for him/her.
Walgreens is helping its customers out yet again this year, by offering free information about the plans. The information is given out by, pharmacists enter a list of a patient’s medications and the computer prints out information that gives a detailed list of plans and estimated annual costs including premiums and co-pays, coverage through the “doughnut hole”, savings with generics versus brand name drugs and 90-day supply allowances. This system also allows pharmacists to ask a few questions to determine whether someone may qualify for the Extra Help subsidy, where they pay lower co-payments.
“We understand this decision can be overwhelming, so we are working to make sure people don’t miss out on significant savings because they don’t know how to evaluate their options,” said Kermit Crawford, Walgreens senior vice president of pharmacy services. “We want seniors to know there’s a plan out there that will work for them, and we can help them find it.”
NACDS reaches out to presidential hopefuls, elevating industry’s profile with new campaign
ALEXANDRIA, Va. The National Association of Chain Drug Stores is launching a new outreach and educational effort to Democratic and Republican presidential candidates in an effort to enlist their involvement in and support of community pharmacy.
The first salvo in that new campaign is an open letter to all the presidential hopefuls, published as a full-page ad in today’s edition of The Washington Post. The letter, on NACDS letterhead, is a kickoff to a broad effort to emphasize the value of retail pharmacy to patients and the health care system. It seeks a partnership between the organization and presidential aspirants in their search for solutions to the nation’s increasingly expensive and challenging health care puzzle.
In its open letter, NACDS points out that “there is a community pharmacy, on average, within 2.36 miles of any resident in the United States,” and that “pharmacists are exceptionally accessible and convenient health care providers.
NACDS urges the candidates to “come to a point when government action reflects the health-boosting and money-saving value of medication management, and stops devaluing the services of those who are best equipped to provide it.
“Given the primacy of the issue of health care, campaigning for nomination and election requires a campaign for quality, affordability and accessibility of care,” the group adds. “Let’s work together to unleash the power of community pharmacy in a pro-patient platform.”
NACDS president and chief executive officer Steve Anderson announced the outreach effort today at a health care forum at the U.S. Chamber of Commerce. “We reached out to the presidential candidates today because health care is clearly the major domestic policy issue on the national stage,” he told Chamber members. “With state and federal governments making nearly half of all healthcare payments in the U.S., we want to be part of the health care vision of the future for public payers. But our scope is much larger than that: we want to engage public and private payers and all strategic healthcare stakeholders.”
In addition, said NACDS’ chief executive, “We also reached out to the presidential candidates because we believe that government needs to think anew about the health-boosting and money-saving value of the role of the community pharmacist in medication management. At the same time, government needs to stop devaluing their services.”
In line with the kickoff of the new outreach campaign, Anderson also unveiled a new report from Comstock Consulting Group, LLC, which outlines the value of pharmacist-delivered patient-care services to health plan payers and other stakeholders. The report, based on a survey of health plan payers, was conducted for NACDS’ Value of Pharmacy Committee with support from drug maker Sanofi-Aventis.
“The objective,” he said, “was to identify insights on how we can develop pharmacist-delivered services that are recognized and valued, and ultimately improve the quality of patient care.”
The report cites the need for collaboration between pharmacists, physicians and other health care stakeholders to improve patients’ prevention and treatment of chronic diseases, and notes that “community pharmacy needs to define its future role as a service provider as well as a product provider.”