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The New Jersey Life Sciences Vendors Alliance (NJLSVA) is a coalition of businesses, individuals and academia who provide goods and services to New Jersey’s life sciences companies.

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STAT Pharmalot: Drug Makers Fund More Compassionate Use Programs Than You May Think

Boston, MA, August 4, 2017 — Pharmalot ‘s Ed Silverman reports on STAT News that patient advocates have long complained that drug and device makers do not make enough experimental medicines available, but a new study finds that the industry funds most trials that aim to get such products to patients.

Specifically, companies funded 61 percent of nearly 400 studies that make drugs or devices available to patients prior to regulatory approval, according to the analysis in BMS Research Notes.

And the researchers suggest that, even without federal intervention, industry is “establishing programs to make experimental therapies available to terminally ill patients.”

“There is a track record that demonstrates companies are trying to get these [programs] implemented and actually paying for them,” said Jennifer Miller, a co-author, who is a medical ethicist in the department of population health at the New York University School of Medicine. The researchers scoured the ClinicalTrials.gov database.

Nonetheless, the analysis — which scoured the ClinicalTrials.gov database — also found that 82 percent of the programs were enrolling adults, not children.

This is likely to provide ammunition for critics who say the compassionate use programs are not working and need to be revamped.

Indeed, the findings emerge amid an ongoing effort to pass Right to Try laws, which were promoted in response to criticism that a Food and Drug Administration program to create access to these products is unwieldy and sometimes capricious.

The FDA approves 99 percent of all requests for experimental medicines that are made available through a compassionate use, or expanded access program.

Still, critics argue that the FDA should be cut out of the process to speed patients’ access to these therapies.

For Silverman’s full story, click here.