November 10, 2017
Drug Price Discussion Continues
CVS to offer same-day delivery
CVS has plans to start offering next-day delivery of prescription drugs and same-day service in major cities including Manhattan, Miami, Boston, Philadelphia, Washington, D.C. and San Francisco in response to potential competition from Amazon. Consumers across the country will have access to next-day delivery from local stores. While Amazon has not made a public announcement, the online retailer has acquired permits to be a wholesale pharmacy distributor. Many in the pharmaceutical industry are worried that Amazon will disrupt pharmaceutical business much the same way it has in other consumer markets.
Pharma, hospitals up lobbying efforts on 340B
Drug companies and hospitals are at odds over the 340B program, which aims to offset the cost of medicines for providers that serve low-income patients. The pharmaceutical industry has used ads and lobbying to claim that hospitals aren’t using the savings to help poor patients. The Association of American Medical Colleges, 340B Health, PhRMA, the Biotechnology Innovation Organization and others have collectively retained eight outside lobbying firms this year alone to help advocate their position on 340B. On the other side, hospitals are saying that the pharmaceutical industry has mischaracterized the program and Congress intended for providers to receive the discounts. In addition, Congressional offices are drafting legislation to tightly limit how hospitals use the discounts.
Congress considers repeal of orphan drug incentives
Lawmakers in the House are considering a proposal to end tax breaks for orphan drug development. Critics say some drugmakers exploit the program by designating drugs that have been on the market for years as orphan drugs. The proposal is likely to receive opposition in the Senate, especially from Sen. Orrin Hatch who was a sponsor of the Orphan Drug Act. Experts say that regardless of the outcome of the bill, the proposal has opened up a discussion on a once “untouchable” issue, since opponents of the incentives did not want to seem insensitive to those with rare diseases.
Ohio voters reject drug pricing ballot initiative
Voters in Ohio overwhelmingly rejected a ballot measure aimed at controlling the price state agencies pay for prescription drugs. The Ohio Drug Price Relief Act would have required the state to pay no more for prescription drugs than the Department of Veterans Affairs’ lowest price. About 80 percent of voters rejected the measure. The pharmaceutical industry spent about $50 million to oppose the measure and many voters reported confusion around how the bill would affect drug prices.
FDA works to get Puerto Rico drug manufacturing back up to speed
The FDA is working to help drug manufacturers in Puerto Rico gain access to the island’s rebuilt electrical grid and get back to full production. Puerto Rico produces $40 billion worth of pharmaceuticals for the U.S. and the FDA is looking to ensure critical medicines will be available. The FDA also is monitoring approximately 90 medical products manufactured in Puerto Rico to help prevent shortages, according to an analysis from the agency. More than a month after Hurricane Maria ravaged Puerto Rico, 57 percent of the island is still without power, leaving many manufacturing plants to rely on unreliable generators.
FDA and Pentagon spar over drug and device authorization
The FDA is pushing back against a provision in a defense spending bill that would allow the Pentagon to authorize the emergency use of drugs or devices not approved by the FDA. Under current law, the FDA is the only agency that can authorize the use of a drug or medical product under any circumstances, including during an emergency. However, federal agencies may request emergency-use approval from the FDA for unapproved treatments. Proponents of the provision argue it would provide soldiers access to cutting-edge treatments that could save lives; the FDA argues that bypassing the agency could expose troops to dangerous products, and is instead proposing an expedited process for Pentagon emergency-use requests.
The Opioid Epidemic
Non-opioid painkillers just as effective in study
A study published in JAMA has found that a combination of Tylenol and Advil is as effective at treating pain in the emergency room as opioids. In the study, patients who arrived in the E.R. with moderate to severe pain were provided a dose of acetaminophen randomly paired with ibuprofen or one of three different opioids. The study found pain was decreased about the same amount for all treatments. The study suggests that alternative pain treatments could allow physicians to address the opioid epidemic by cutting down on opioid prescriptions without surrendering treatment for pain.
Industry groups recommend tactics to fight opioid epidemic
In a letter to President Trump, a group of pharmacies, pharmacy benefit managers and health plans pledged support to help combat the opioid epidemic by outlining several recommendations including limiting prescriptions to a seven-day supply, electronic prescribing, alternative treatments, lower dosages and closer oversight. The recommendations align with the CDC’s updated prescriber guidelines, which were released in August 2017. Some pharmacies, insurers and drug distributors are already taking steps to reduce opioid addiction, including Intermountain Healthcare, which pledged to lower the number of opioid prescriptions written by 40 percent next year.
CMS fails to identify beneficiaries at risk of opioid addiction
The Government Accountability Office released a report that found CMS overlooked hundreds of thousands of seniors using prescription painkillers who are at risk for addiction. The report notes that several changes are necessary for CMS to improve the tracking of Medicare patients who may be overprescribed opioids. The recommendations include gathering more information on the number of Medicare beneficiaries at risk of harm, looking into providers who prescribe high amounts of opioids and reporting to CMS the results of provider investigations.
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