ACHP Media Report: Pharmacy News – April 7, 2017

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ACHP in the news: ACHP sent a letter to Congressional leadership urging them to fund cost sharing reductions for Americans purchasing health insurance coverage on the federal and state-based marketplaces. President and CEO Ceci Connolly discusses the importance of funding to stabilize the market and ensure affordable coverage for millions of Americans in Modern Healthcare and CNBC.

Connolly also explains how PhRMA deflects the debate over high drug prices in Health News Review.

FDA Highlights

Gottlieb defends his FDA nomination
Dr. Scott Gottlieb, President Trump’s nominee to lead the Food and Drug Administration, testified before the Senate Health, Education, Labor and Pensions Committee on Wednesday. Democrats questioned whether Gottlieb’s ties to the pharmaceutical industry would compromise his ability to act impartially. Gottlieb largely deflected criticism about ties to drugmakers at the hearing.

Gottlieb said that his first priority as FDA commissioner would be finding ways to fight the nation’s opioid crisis. He called for re-evaluating the current framework for how the FDA develops alternatives to opioid drugs, and is also looking at medical devices and medically assisted therapy to help people struggling with addiction.

At the hearing, Gottlieb also pledged to maintain the FDA’s gold standard for regulation while improving efficiency and ensuring drug safety. Gottlieb appears to support efforts to improve market competition, including expediting approval of generic drugs to lower prices as well as making biosimilars more interchangeable with branded versions. Gottlieb also feels there are ways to speed up some clinical trials without sacrificing the regulatory gold standard.

According to a recent study, the U.S. already outpaces the European Union when it comes to drug approvals. Between 2011 and 2015, the U.S. FDA approved 170 drugs in 306 days. Its EU counterpart approved 144 drugs in 383 days.

FDA considers direct-to-consumer marketing
In a shift from past positioning, the FDA plans to allow 23andMe to sell genetic testing for disease risk directly to the consumer. This shift is expected to open the door for other companies to also sell direct to consumer tests for disease risk.

Federal and state efforts take steps to address opioid epidemic

New Mexico Requires Law Enforcement to Carry Naloxone
New Mexico is the first state to require all local and state law enforcement agencies to provide officers with antidote kits to help prevent opioid overdoses. Clinicians in New Mexico are also required to complete training for prescribing painkillers. The state was the first in 2001 to increase access to naloxone and a few years later it led the way to release people from legal liability when they assist in overdose situations. New Mexico also was the first state to allow pharmacists to dispense naloxone without a prescription in an effort to expand access to the life-saving drug.

States get waivers to increase access to treatment
As the opioid epidemic continues, states are seeking funding from Medicaid to increase the number of beds allowed in residential treatment facilities. The federal government has provided a waiver for Maryland, California, Massachusetts and New York, overriding the prohibited use of federal funds in facilities with more than 16 beds. Stateline mentions several other states are seeking this waiver, and it is likely they will receive them based on HHS Secretary Tom Price’s statement earlier this year about continuing the program.

Delaware legislation would ensure treatment is covered
Legislation sponsored by Delaware State Rep. Helene Keeley (D-Wilmington) focuses on ensuring those with private and public insurance have access to substance abuse treatment. The bill also allows the attorney general to provide legal assistance and requires Medicaid and private insurers to notify individuals of legal help to assist with denied claims. The Washington Post points out related legislation passed in the state Senate this week removing roadblocks, such as prior authorizations and required referrals, to treatment.

Holding makers of opioid accountable
The government has struggled to hold opioid manufacturers accountable. A long-format piece in the Washington Post details a 2011 DEA case targeting Mallinckrodt Pharmaceuticals, one of the largest makers of oxycodone. Despite findings that Mallinckrodt dodged its duty to report suspicious orders, no legal action has been brought against the company. The DEA found that 500 million pills in the state of Florida, 66 percent of all oxycodone sold there, were manufactured by Mallinckrodt.

The Cost of Prescription Drugs

Strategies to address high prices abound
Tom Price, Secretary of HHS, plans to work with President Trump to bring down the cost of drugs. While he did not provide specifics, the Regulatory Focus notes Price’s approach is likely to revolve around Trump’s statements related to CMS being able to negotiate drug prices.

In a push for President Trump to act on his promise to address the high price of drugs, more than 50 democratic lawmakers signed a letter urging Trump to override patents for drugs discovered with federal funds but priced out of reach of many consumers. The letter calls for Trump to instruct the National Institutes of Health to override patents for medicines that were discovered with federal funds, but carry price tags that are out of reach for many Americans.

Mylan’s troubles continue
A widespread recall of Mylan NV’s EpiPen now includes the United States. The recall was prompted by two reports of a potential defect in EpiPen devices. STAT News emphasizes this recall does not include Mylan’s generic product.

The company has also been served with a lawsuit by EpiPen patients alleging Mylan NV overcharged them in an illegal pricing scheme to secure sales. The Wall Street Journal reports.