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Drug cost conversation continues
Drug price data may soon be available
In the face of increasing political pressure over rapidly rising drug costs, electronic health record companies and pharmacy benefit managers (PBM) are developing tools that would enhance drug pricing transparency for consumers by providing up-to-date information on pricing. While the applications are not yet in release-ready form, they will provide an additional tactic for advocates struggling to understand high drug costs. Drugmakers and PBMs have come under fire for opaque and complex pricing structures and overall lack of transparency.
Powerful patient testimony from CSRxP
The Campaign for Sustainable Rx Pricing (CSRxP) has released an ad featuring testimony from a family whose yearly prescriptions cost almost $85,000. Drug prices have a significant impact on family incomes and some consumers are forced to choose between paying for life saving medications or daily living expenses.
FDA to require more training for IR opioids
In order to combat the opioid epidemic, the FDA will require drugmakers to provide additional training to providers who prescribe immediate release (IR) opioids, including training in alternative pain management approaches. The agency will also survey doctors on their understanding of abuse-deterrent products. Over prescription of opioids has played a central role in driving the epidemic, and FDA Commissioner Scott Gottlieb, M.D., believes many providers are still writing too many 30-day prescriptions for minor surgical procedures.
Crackdown on substance abuse treatment fraud
Shoddy and fake treatment centers are increasingly exploiting patients with opioid use disorders as part of a wide-sprawling insurance fraud scheme. Some treatment centers are paying marketers and brokers to enroll opioid addicts in subpar and sometimes nonexistent treatment programs. Patients receive little to no assistance with their addiction, but the centers collect large fees from insurers.
Attorney General Jeff Sessions has announced a massive crackdown on opioid-related fraud cases. Federal officials have arrested 120 people across the country, including doctors who are accused of running pill mills and treatment center operators accused of insurance fraud.
User Fee Agreement passes House
The FDA Prescription Drug User Fee Agreement Reauthorization passed the House with bipartisan support and includes agreement on user fee levels from drugmakers and device companies that fund the majority of FDA’s budget to review and approve new products. The bill faced some criticism for relaxing reporting standards for medical device makers, among other issues. The bill now goes to the Senate.
FDA committee recommends first gene therapy for approval
An FDA advisory committee unanimously recommended that the agency approve the first-ever treatment that genetically alters a patient’s cells to fight cancer. Altered cells would boost the immune system to shut down the disease. If the FDA accepts the recommendation, the leukemia treatment will be the first gene therapy of its kind to reach the market. Patients and advocates are recommending approval because of its promise as an alternative to chemotherapy and radiation.
Half a million Medicare patients were overprescribed opioids last year
A government watchdog report finds that about 500,000 Medicare patients took quantities of prescription drugs deemed too large by CDC standards in 2016. Nearly 70,000 Medicare beneficiaries received amounts of narcotic painkillers equivalent to 240 milligrams of morphine every day for a year. The report also showed a pattern of “doctor shopping” for drugs, despite state databases established to curb the trend.