Pharma Industry News Update: 23 May 2017

Califf Embraces Digital Health
Will Join Google’s Life Sciences Tech Arm Verily

[From and STATnews] Califf would join shortly after the launch of Verily’s baseline study, a well-funded effort headed up by fellow cardiologist Jessica Mega to study human health by tracking 10,000 people over at least 4 years.

“I’m hoping to offer insights that will allow the company to better tailor its technologies to meet the needs of doctors, other providers, health systems and the patients they serve, and to drive evidence-based approaches that will enable continuous learning and improvement,” Califf wrote in his announcement of the news on the Verily blog, though he didn’t specifically say what role he’d be taking in the company.

“Although we are in the midst of an explosion of capability in the worlds of computing and information, we have not yet learned how to effectively translate this capacity into better health and health care,” Califf wrote. “Bridging this gap… [is] at the heart of what I’m hoping to accomplish.”

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FDA Also Embraces Digital, But…
It May Focus Less on Compliance & More on Reputation

[From] The FDA is creating a new unit dedicated strictly to digital health. Bakul Patel, policy advisor to FDA, will be hiring 13 engineers — software developers, AI experts, cloud computing whizzes — to prepare his agency to regulate a future in which health care is increasingly mediated by machines.

“We’ve been trying to translate the current regulation paradigm for digital,” he says. “But what we have today and what we’re going to have tomorrow are not really translatable. We need to take the blinders off, start with a clean sheet of paper.”

Rather than reviewing each line of code or medical device on its own merits for each of its intended uses, Patel wants to flip that framework on its head. “The idea is to get safe products to market faster, by having people compete on excellence rather than compliance,” he says.

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PharmaGuy’s insight:
FDA is being pushed from all sides to get products to market faster rather than getting safe products to market. Even “excellent” Google has screwed up when it comes to developing digital health apps!

Restricting Gifts to Doctors

[From] California State Senators approved legislation on Thursday, May 18, 2017, that would restrict pharmaceutical makers and other drug companies from giving gifts to doctors and other medical professionals. The legislation, SB 790, was penned by State Sen. Mike McGuire and passed by a vote of 23-13.

SB 790 would prohibit or restrict most gifts from drug makers to doctors. Sen. McGuire said the bill would lower the cost of drugs in California because it would prevent doctors from receiving gifts that encourage the prescription of expensive drugs.

SB 790 would still allow doctors to be paid salaries for running clinical trials, and companies can still pay for meals, as long as the costs are below $250 per year per doctors. Even with these exceptions, the bill is still fiercely opposed by the pharmaceutical industry’s main lobbying group.

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