Pharma Industry News Update: 28 July 2017

Celgene Settles $280 Million Fraud Suit

Promoted Cancer Drugs Off-Label

[From] The pharmaceutical company Celgene has agreed to pay $280 million to settle claims that it marketed the cancer drugs Thalomid and Revlimid for unapproved uses, the company said on Tuesday.

 Under the terms of the settlement, which resulted from a lawsuit filed by a whistle-blower – a former sales representative at Celgene – the company will pay $259.3 million to the United States and $20.7 million to 28 states and the District of Columbia.

Cancer drugs are seen as more difficult to pursue in so-called off-label marketing cases in part because oncologists often prescribe drugs for unapproved uses in an effort to combat a deadly and still mysterious disease.

“The company got the idea that it could be fast and loose with what it was saying about its drug because it was selling to cancer patients who might be in need,” Mr. Guttman said. “At the end of the day, what this is about is that even when you’re on life’s edge,” he added, a company “can’t break the law by off-label marketing a drug.”


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FDA is Looking for a Few Good Digital Health Product Developers

Who Will Be the Lucky Nine?

[From] FDA announced, as part of its broader Medical Innovation Access Plan, a new component focused on digital health innovation – the formal launch of its Pre-Cert for Software Pilot Program.

This new program embraces the principle that digital health technologies can have significant benefits to patients’ lives and to our healthcare system by facilitating prevention, treatment, and diagnosis; and by helping consumers manage chronic conditions outside of traditional healthcare settings.

At the same time FDA announced this pilot, FDA’s Center for Devices and Radiological Health (CDRH) is publishing its Digital Health Innovation Action Plan to provide details and timelines for FDA’s integrated approach to digital health technology and the implementation of the 21st Century Cures Act. FDA is telling consumers and the digital health industry how it will establish clear and consistent expectations for the products FDA regulates.

FDA designed the new digital health pilot program to include up to nine software firms of various sizes. Initial participants in this new pilot will range from small startups to large companies that develop both high- and low-risk software products that are devices.

Learn how to qualify for the program…

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FDA Making “PEACe” with Patients

Schedules First Ever Patient Engagement Advisory Committee Event

[From] This week marks a new milestone in the arc of progress that has been patient involvement since that time. FDA announced in a blog posting on FDA Voice, and in a Federal Register notice, that the inaugural meeting of the Patient Engagement Advisory Committee (PEAC) will be held in October. The first meeting will take place on October 11 and 12 and the agenda is focused on getting input into getting patient input into medical device trials. 

The current roster of the committee has 9 members, two of whom are from disease-specific organizations – the American Association of Kidney Patients and the Arthritis Foundation. Other member slots represent individuals who work in the area of patient engagement. At least one person appears to be experienced in minority outreach, but unlike other FDA Advisory Committees, the CV’s of the members are not yet linked to their names on the current roster listing.

The launch of the committee is an important step, but it is important to note that it is one step in a much longer journey.

More here…

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