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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.

The NJLSVA was founded to educate suppliers on trends in industry procurement and public policy that affects the life sciences industry.

Pharmalot: FDA to Hold Two-Day Meeting on Off-Label Drug Marketing

STAT PharmalotBoston, MA, November 8, 2016 ― Pharmalot reporter-blogger Ed Silverman reports on STAT that, after years of anticipation, the U.S. Food and Drug Administration (FDA) will hold a public, two-day meeting starting on Wednesday to review the extent to which so-called off-label information about medicines may be disseminated to physicians.

Nothing will get decided, though.  The meeting is designed simply to give the public — drug makers and patient advocates alike — a long-awaited chance to convey their opinions and debate the issue.

Off-label information refers to materials that describe unapproved uses of a drug.  

Doctors are allowed to prescribe a medicine for an unapproved use, but drug makers have long battled restrictions on their ability to distribute this type of information — such as reprints of medical studies — and have lobbied Congress and the FDA to loosen regulations.

The FDA, however, has avoided doing so.  The agency has regularly voiced concern that public health could be jeopardized if a drug maker distributes information about an unapproved use that has not been proven safe or effective.

As STAT has reported previously, the industry effort accelerated after a 2012 ruling by a federal appeals court that overturned the criminal conviction of a Jazz Pharmaceutical sales rep, who was prosecuted for encouraging doctors to prescribe a drug for unapproved uses.

The court ruled his speech was protected, since the information was truthful and not misleading.

For Silverman’s full STAT story, click here.

Follow Silverman’s Pharmalot on Twitter @pharmalot.


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