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Trending News Today: Investigation Finds Flaws in Orphan Drug Program

Top news of the day from across the health care landscape.
Published Online: Dec 03,2018
AJPB Staff
Amazon’s ongoing push to enter the pharmacy market may be inhibited by the stringent requirements associated with obtaining the various US state licenses required to market drugs and devices, according to an article by STAT. The report noted that several errors by PillPack, which Amazon acquired earlier this year for $1 billion, illustrate the myriad issues the retail giant faces in disrupting this key growth area. According to STAT, PillPack was initially denied a pharmacy license in New Mexico because of incomplete information.

GOP legislators appear to be abandoning their goal of cutting federal funding for Planned Parenthood, according to a report in Politico. A lame-duck session of Congress convened this week and failed to garner support for a last-ditch effort to push through cuts to Planned Parenthood, a repeal of the Affordable Care Act, and other legislative priorities, the article reported. Republican congress member indicated the futility in passing a bill that will fail in the upper chamber, with conservative bills that might gain support in the Senate will ultimately collapse in the new Democratic-led House next year, according to Politico.

A federal report found that the FDA failed to ensure that drugs awarded Orphan Drug Designation matched the intent of the 35-year-old law, according to an article by Kaiser Health News. An investigation by the Government Accountability Office found inconsistent and incomplete reviews in the designation of certain medicines as orphan drugs and recommended action to repair the flaws in the system, according to Kaiser. The article noted that FDA reviewers, in some instances, failed to check how many patients could be treated by a medication being evaluated for orphan drug status and instead appeared to trust what they were told by the drug manufacturers.