WASHINGTON — Legislation proposed in the House of Representatives would speed up Food and Drug Administration approval of knock-off versions of vaccines and other biologics while requiring the agency to conduct more inspections of drug factories overseas, according to published reports.
News media reported last month that the bills, sponsored by Rep. Tim Murphy, R-Pa., would create an expedited FDA approval pathway for follow-on versions of biogenetic medications, such as vaccines and drugs made from human tissue and plasma. According to media reports, Murphy said the legislation would make the medications more affordable and accessible while ensuring that offshore drug makers are held to the same manufacturing standards as those based in the United States.
According to reports, the House Energy and Commerce Committee voted 46-0 to send the bill to the House floor.
MONTGOMERY, Ala. — A new law in Alabama will establish standards in the pharmacy audit process conducted by pharmacy benefit managers in the state. Last month, Alabama Gov. Robert Bentley signed SB 383, the Pharmacy Audit Integrity Act, which establishes uniform standards for the auditing of pharmacy records and includes requiring two weeks written notice of an audit. The law also requires audits that involve clinical or professional judgment be conducted in consultation with a pharmacist and establishes an appeals process.
The bill drew praise from the National Association of Chain Drug Stores, which has endorsed federal legislation that seeks to preserve pharmacy choice for patients and takes additional steps to prevent threats to pharmacy patient care. The bipartisan Pharmacy Competition and Consumer Choice Act — S. 1058 and H.R. 1971, sponsored by Sen. Mark Pryor, D-Ark., and Rep. Cathy McMorris Rodgers, R-Wash., respectively — includes provisions requiring transparency by PBMs in pharmacy audits.
MONTPELIER, Vt. — Vermont also enacted a PBM audit law, which drew praise from NACDS as well. S. 200, signed into law by Vermont Gov. 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.
“We thank Gov. 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.”