ACHP Media Report: Pharmacy News – September 1, 2017

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Drug cost conversation continues

Penalty for overcharging 340B providers delayed
The Trump Administration may further delay a rule that would hold drugmakers accountable for overcharging providers for drugs purchased under the 340B discount program. The rule was originally scheduled for implementation in March this year but was delayed until October; officials now say the rule may not go into effect until almost a year from now. Once implemented, drug companies who violate the rule would have to reimburse providers and face fines up to $5,000. The Administration is accepting public input on the delay.

Gilead under fire over acquisition and patent settlement
Gilead Sciences purchased California-based Kite Pharma for $11.9 billion, giving Gilead control over some of most in-depth research and development into CAR-T, a breakthrough cancer treatment that is drawing controversy for high prices. Gilead refuses to comment on drug pricing until the acquisition is official later this year. Gilead Sciences has also come under criticism from AIDS activists who allege the drugmaker violated antitrust laws in a previous patent dispute settlement by using the settlement as an excuse to forestall the development and sale of generic versions of an HIV drug. It’s unclear if this would constitute antitrust violation, but the Supreme Court has ruled such deals can face antitrust scrutiny.

Breakthrough leukemia treatment comes with high price tag
Novartis’ breakthrough leukemia treatment, Kymria, was approved by the FDA this week. Kymria will cost $475,000, drawing criticism from drug pricing advocates. Novartis is defending the cost by citing the drug’s effectiveness and noting the high cost of other treatments, including bone marrow transplants. The drugmaker also says patients who do not react positively to treatment within a month will not be charged. The treatment genetically alters patients’ cells in order to kill cancer and in trials resulted in 83 percent of Kymria patients going into remission within three months.

CVS price-gouging lawsuit dropped
A lawsuit alleging CVS is price gouging by charging noninsured customers more than insured customers has been dropped. CVS claims the lawsuit was withdrawn after it contacted Hagens Berman, the law firm representing the plaintiff, and pointed out numerous factual inaccuracies in the filing. Hagens Berman says it plans to refile the suit soon, and notes it is still pursuing another suit it has pending against Walgreens.

FDA Happenings

FDA steps up stem cell enforcement
Stem cell clinics offering treatments not approved by the FDA have become more common in recent years. Many offer fat-derived injections that supposedly treat ailments from hip and knee problems to autism and Alzheimer’s disease. The FDA is stepping up oversight of stem cell clinics to prevent the use of unapproved treatments, sending a warning to letter to a Florida clinic and marshals to a San Diego clinic last week. In a recent statement, FDA commissioner Scott Gottlieb warned of further actions against clinics who are using unapproved products that could put patients at risk.

Opioid epidemic

Advocates, officials petition FDA on opioid dosage
State health officials and safety advocates have filed a petition with the FDA to limit the production of high-dose opioid painkillers. Citing CDC safety recommendations, the petitioners asked the FDA to ban pills that, when taken as directed, would equal a dosage of more than 90 milligrams of morphine. FDA officials have declined to comment on the petition.

States take action against pharma companies
Officials in more than 20 states are claiming drugmakers fueled the opioid crisis with misleading ads and aggressive distribution. Missouri Attorney General Josh Hawley is investigating seven pharmaceutical companies’ marketing tactics around opioids. Allergan, Depomed, Insys, Mallinckrodt, Mylan, Pfizer and Teva Pharmaceuticals will be required to turn over writings, recordings, photographs and electronic files related to the sale, advertisement or promotion of the drugs. The lawsuits are part of a growing trend that aims to change drugmakers practices and hold them accountable for expenses related to addiction.

Overdoses rise in Ohio
Each day last year, an average of 11 people died due to drug overdoses in Ohio. Officials reported overdose deaths rose 33 percent in 2016 compared to 2015. The Health Department attributes the record number of fatalities to the appearance of stronger drugs, like fentanyl and carfentanil, an opioid so powerful it’s used to sedate elephants. The Health Department also reports prescriptions for painkillers are falling, an important step in curbing addiction rates.