The FDA issued a statement Tuesday explaining the causes and progress being made toward resolving critical shortages of I.V. fluids, injectable opioid pain drugs and Mylan NV's Epipen (epinephrine) auto-injector. The statement came on the heels of a bipartisan letter from more than 30 U.S. senators expressing concern about ongoing drug shortages. The senators noted a recent member survey conducted by the American Society of Anesthesiologists in which 98 percent of the respondents indicated they regularly experience anesthesiology drug shortages and 95 percent said the shortages adversely affect patient care. The letter cited a similar survey by the American College of Emergency Physicians in which 91 percent of respondents noted that they have experienced shortages or absences of critical drugs. According to the FDA's 2017 annual report to Congress on drug shortages, released last week, the agency worked with manufacturers to prevent 145 drug shortages last year. While 39 new shortages still occurred during 2017, that number was far lower than the peak of 251 new shortages experienced in 2011, Douglas Throckmorton, deputy center director for regulatory programs in the FDA's Center for Drug Evaluation and Research, said in Tuesday's statement. "We recognize that many of these shortages have been for critical drug products and that they are having a tangible impact on patients," he added.
The Medicaid and CHIP Payment and Access Commission (MACPAC) is recommending a change to statutory provisions that prevent state Medicaid programs from paying the lowest price for certain drugs. To tackle rising drug costs, MACPAC advised Congress to close a loophole that currently allows a manufacturer to sell its authorized generic at a low price to a corporate subsidiary, reducing the rebate obligation for its brand drug. The commission also advised giving the Health and Human Services secretary clear authority to impose intermediate financial sanctions on manufacturers that misclassify a brand drug as a generic to lower their Medicaid rebate payments.
Observations made during an inspection at Oeyama-Moto Medical Group Foundation Inc., of West Covina, Calif., last August raised FDA concerns about the validity of nonclinical data generated by the testing facility, according to a warning letter the agency posted Tuesday. Management of the testing facility "failed to fulfill the primary responsibilities to establish appropriate policies and procedures intended to ensure the quality and integrity of nonclinical data for FDA submission," according to the letter. Additionally, the FDA said the study director's oversight deficiencies and the absence of an independent quality assurance unit indicated that the testing facility "failed to fulfill the core responsibilities to remain GLP-compliant."