The U. S. House of Representatives passed multiple bills last week addressing the opioid crisis, including legislation enforcing new requirements for the Drug Enforcement Administration (FDA) to inform pharmacists when they may refuse to fill a prescription of a controlled substance. The proposal, H. R. 4275, will help pharmacists detect fraudulent prescriptions, and require federal agencies to develop and disseminate materials giving pharmacists greater understanding and ability to decline to fill controlled substances when they suspect the prescriptions are fraudulent, forged, or appear to be for abuse or diversion.
Also passed was H. R. 5009 which requires the Health and Human Services secretary to develop guidelines for health care providers regarding the sharing of a patient’s history of addiction. The bill “Jessie’s Law” is named after Jessie Grubb of Charleston, WV, who died after her physician prescribed her 50 oxycodone pills for a running-related injury — not knowing she had addiction problems. West Virginia Senators Joe Manchin and Shelley Moore Capito introduced the bill.
Established by Governor Jim Justice, twenty-two public hearings have been held around the State to hear comments from PEIA insureds regarding their continued increase in premiums and declining benefits. Covering over 200,000 persons, the cost of PEIA has increased $50 million year over year. Legislative measures to ease the financial problems can be expected during the 2019 Legislature.
Mylans’ first FDA-approved biosimilar drug should be available in a matter of weeks, a company official said. Mylan along with Biocon received the approval for Fulphila, a biosimilar to the drug Neulsts, which targets infections suffered by some breast cancer patients as they are undergoing chemotherapy.
S. 2460 passed by the U. S. Finance Committee will require electronic prescribing for Schedule II through IV controlled substances prescriptions covered under Medicare Part D.
FDA estimates generic drugs approved in 2017 led to $11.8 billion in savings through February 2018. The estimate is based on pharmacy acquisition costs and does not reflect rebates, discounts, or off-invoice adjustments. The FDA approved a record 1,027 abbreviated new drug applications in 2017, 843 of which were fully approved.
Nine (9) online networks covering 53 websites received warning letters from the FDA to stop marketing unapproved and misbranded versions of opioid medications. “The internet is virtually awash in illegal narcotics and we’re going to be taking new steps to work with legitimate internet firms to voluntarily crack down these sales,” said FDA Commissioner Scot Gottlieb, M.D.