Pharmalot, Pharmalittle: DEA slowed enforcment even as opioid epidemic raged

Hello, everyone, and welcome to another working week. We hope the weekend respite was enjoyable and refreshing, because that familiar routine of meetings, deadlines, and the like has returned with a vengeance. And there is nothing like a refreshing cup of stimulation to help us along. So please feel free to indulge yourselves. Meanwhile, here is the latest list of tidbits. Hope your week gets off to a smashing start and do stay in touch …

A Drug Enforcement Administration campaign to curb the opioid epidemic was slowed by pharmaceutical industry lobbying, The Washington Post reports. The agency began targeting wholesalers that distributed pills to corrupt pharmacies and pill mills that illegally sold the drugs for street use. But after the Office of Diversion Control filed civil cases against the distributors and issued orders to immediately suspend the flow of drugs, former DEA and Justice Department officials hired by drug makers began pressing for a softer approach.

GlaxoSmithKline chief executive Andrew Witty tells The New York Times this about drug pricing: “Even when you look at the United States — I can’t tell you this is a proven experiment — but if you look at GSK the last five or six medicines we’ve launched, we’ve launched at or below the prices of the technologies that we’re aiming to replace. We’ve never had better new product sales. And the reason why is we’re accessing bigger volume more quickly.”

The National Cancer Institute determined some of its lymphoma researchers failed to notify the Food and Drug Administration on a timely basis about fungal infections that resulted in two deaths of patients in one of its research studies, The Wall Street Journal reports. Two patients died from an infection of a commonly occurring fungus called aspergillus in 2015, but the deaths were not reported until May 2016. Notification is required in days.

The future of the UK life sciences industry looks more uncertain after government ministers discounted a report that proposed what the sector needs to thrive outside of the European Union, including funding, talent, and trade issues, The Telegraph reports. “It was basically the industry whining about Brexit and it was not very constructive and has gone straight into the hopper,” a government source told the paper.

The UK government published long-awaited findings of an independent accelerated access review process, PharmaTimes reports. The idea is to ensure that patients can benefit from innovative new diagnostic tools, drugs, digital health care, and medical technologies much more quickly. Theoretically, the effort could speed patient access to drugs by up to four years.

GlaxoSmithKline is seeking FDA approval for a shingles vaccine that analysts estimate could generate more than $700 million in sales and compete with Merck’s Zostavax, Bloomberg News says. Meanwhile, Glaxo is ending US sales of its Cervarix HPV vaccine due to “very low market demand,” according to a note to suppliers, which was reported by Fierce Pharma.

Merck won FDA approval for a drug called Zinplava to prevent the recurrence of Clostridium difficile, or C. diff, infections and plans a launch for early 2017, PharmaTimes writes.

The FDA says that pharmaceutical ingredients made by Laxachem Organics were not the source of bacteria in Pharmatech laxatives linked to a spate of Burkholderia cepacia infections, InPharma Technologist reports.

Chinese authorities last month rejected 30 new drug registration applications due to fabrication of clinical trial data, Xinhua reports.

A lawsuit filed by 63 women in Japan who say they were harmed by HPV vaccines — and sued the government, Merck and GlaxoSmithKline — will hinge on over their ability to provide scientific evidence, The Japan Times says.