Generic Drug User Fee Act passes in Senate
WASHINGTON — The generic drug industry has applauded the passage of legislation that will expedite the Food and Drug Administration’s review of generic drugs and biosimilars, as well as enhance the agency’s ability to inspect foreign manufacturing sites.
The Generic Drug User Fee Act, which passed in the Senate on Thursday, is designed to provide the FDA with additional resources and ensure all participants in the U.S. generic drug system — whether U.S.-based or foreign — comply with strict quality standards to ensure all Americans receive timely access to safe, effective and affordable generic drugs. The GDUFA calls for the generic drug industry to pay $299 million annually in user fees for the next five years, beginning Oct. 1.
The Generic Pharmaceutical Association, which applauded the legislation, said the user fee programs are part of GPhA’s multipronged effort to ensure patients have access to lifesaving generic medicines.
"The Senate’s vote [today] is another critical step in ensuring patients will have access to the lifesaving generic medications they require for years to come," GPhA president and CEO Ralph Neas said. "The Generic Drug User Fee Act will expedite the availability of low-cost, high-quality generic drugs to Americans and further safeguard the quality and accessibility of our nation’s drug supply. We urge the House to continue the remarkable bipartisan cooperation shown throughout this process and approve the legislation in a timely manner so that patients, the FDA, and generic manufacturers can begin to see its many benefits."
NACDS praises enactment of PBM audit legislation in Vermont
ALEXANDRIA, Va. — Legislation enacted in the state of Vermont, which establishes standards in the pharmacy audit process conducted by pharmacy benefit managers, has been applauded by the National Association of Chain Drug Stores.
S. 200, signed into law by Vermont governor Peter Shumlin, establishes consistent standards for the auditing of pharmacy records and includes requiring two weeks written notice of an audit; requires auditing records be provided to the pharmacy; sets a 60-day deadline for the preliminary audit report following completion of an audit; and establishes a written appeals process. Similar legislation has been enacted in such states as Alabama and Minnesota.
"We thank Governor Shumlin for enacting this important pro-patient, pro-pharmacy legislation to curb practices used by some PBMs that jeopardize the role of community pharmacy in improving patient care and making healthcare delivery more efficient and cost-effective," NACDS president and CEO Steve Anderson said. "We thank the Vermont Association of Chain Drug Stores for their leadership in helping to ensure transparency in the PBM audit process."
NACDS lauds prevention of ‘personal importation’ of prescription medications
ALEXANDRIA, Va. — Following the Senate’s defeat of a proposal that would have permitted “personal importation” of prescription drug medications, the National Association of Chain Drug Stores lauded the Senate’s decision to support patient safety.
During debate of the Prescription Drug User Fee Act on Thursday, Sen. John McCain, R-Ariz., proposed an amendment that would have allowed an individual — not in the business of importing a prescription drug — to import prescription drugs from Canada. NACDS warned that such action would lead to the sale of reimported drugs on websites not associated with licensed pharmacies, further jeopardizing patient safety.
“We thank the Senate for its leadership in protecting patients,” NACDS president and CEO Steve Anderson said. “NACDS shares the goal of reducing the cost of prescription drugs. However, we do not believe that patient safety can be ensured under a prescription drug reimportation system.
"In addition to questions concerning the safety and effectiveness of imported drugs, individuals who obtain medications through personal importation are less likely to benefit from the professional services of their local, licensed community pharmacist,” Anderson said. “Community pharmacy offers various patient services including screenings, health education and wellness programs, vaccinations, and medication therapy management services to help patients understand the importance of taking medications as prescribed — all of which can help patients live healthier and reduce overall healthcare costs.”
Following Senate passage of the bill this week, the House will vote on their version of PDUFA as early as next week. The Senate and House will work to reconcile their respective versions next month. NACDS stated that, throughout this process, it will continue to work with lawmakers to ensure the health and safety of patients served by community pharmacy.