iLoveBenefits: Industry News Blog

What C-Suite Executives Want in 2017

Informed consent the electronic way

FDA released draft guidance last week outlining ways for clinical investigators, sponsors and institutional review boards to use electronic media to obtain patients’ informed consent for clinical investigations, reacting to researchers’ increasing interest in using electronic media instead of the traditional written informed consent document.

Will vaccines hit the mark next flu season?

Changes to flu vaccine for 2015-16 season recommended by FDA committee The FDA’s Vaccines and Related Biological Products Advisory Committee recommended an overhaul for the influenza vaccine for the 2015-16 season after the vaccine for the 2014-15 season proved to be largely ineffective. This season’s vaccine did not include the A/Switzerland/9715293/2013-like virus, which turned out to be the most prevalent strain. The World Health Organization has recommended it be included in next year’s vaccine, along with a new H1N1 A strain, A/California/7/2009 pandemic09-like virus, and B/Phuket/3073/2013-like virus, a new B strain. The FDA and CDC concur with the WHO’s suggestion. Medscape (free registration)

Comparative Effectiveness Needs to Extend to Labeling

Advocates To Lobby Congress If CER Omitted From FDA Drug User Fee Talks

Advocates would like to see FDA mandate a three-armed trial to test products against the best current practice as part of the pre-approval process — which would require new authority from Congress. By bolstering FDA’s ability to conduct pre-approval CER, the agency could become the federal government’s central comparative effectiveness information clearinghouse, possibly even beyond the new healthcare reform-created public-private partnership, sources say. The Patient-Centered Outcomes Research Institute’s budget will likely gradually increase from $10 million this year to $150 million by 2012, funding levels that might not generate significant data due to high clinical trial costs, a source said.

Sources from several different advocacy organizations said they will place a high priority on comparative effectiveness in the next and fifth authorization of the Prescription Drug User Fee Act, although industry is expected to hotly contest any effort to inject CER into the product approval process.

If FDA fails to include comparative effectiveness provisions in its PDUFA V legislative request to Congress, the advocacy groups will shift their strategy to target lawmakers’ offices, where sources said they will press for several CER provisions to be added to both drug and device user fee re-authorizations.

“We think this is very, very important and are going to push it hard,” a consumer advocate said. “The potential in PDUFA V is for getting the FDA into really being the leaders in bringing the world scientific information that lets you know what works best and is the safest.”

Ethical Issues in Studying the Safety of Approved Drugs

 

The side effects of some drugs may not appear until after the FDA has approved them. In this report, the IOM offers an ethical framework to help the FDA decide when to require clinical trials to assess a drug’s safety after it is on the market.

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