Who We Are

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.

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Choose New Jersey’s RFP Watch provides up-to-date information on business opportunities throughout the Garden State at a cost that is affordable for all companies – with a place of business in New Jersey – large and small.

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User Fees

Trump Signs FDA User Fee Agreement into Law; PhRMA and BIO Applaud the Move

Washington, DC, August 21, 2017 — President Donald J. Trump on Friday signed into law a funding package for the Food and Drug Administration (FDA) that also takes steps to lower drug prices.

The FDA Reauthorization Act (FDARA) of 2017 reauthorizes a program in which drug and medical device makers pay the FDA a fee for every new product application.  The agency uses those funds to hire more people and speed up approvals.

The user fee program must be reauthorized every five years. The current program expires at the end of September, and if it hadn’t been signed into law before then, the agency would have had to lay off workers. Continue reading

Trump Will Sign FDA User Fee Reauthorization Bill, Ending Threat of Agency Layoffs; Industry Praises Move

Washington, DC, August 8, 2017 — Zachary Brennan reported on Endpoints News that President Donald J. Trump will sign bipartisan legislation, passed by the U.S. Senate on August 3, that reauthorize the Food and Drug Administration (FDA) user fee programs for prescription drugs, generic drugs, medical devices and biosimilars for the next five years.

A spokesman for President Trump told Focus, “The President will sign this bill, but we look forward to working with Congress to address further negotiations.”

The Senate’s passage of the House bill by a vote of 94-1 — Bernie Sanders (D-VT) was the only vote against — came more than two years after negotiations on the reauthorization began. Continue reading

FDA Commissioner Delays Layoff Notices and Reassures Staff Congress Will Reauthorize User Fees

FDA Commissioner Scott Gottlieb, M.D.

Washington, DC, July 27, 2017 — Michael Mezher reports on Endpoints News that, in a July 24 email to agency staff, FDA commissioner Scott Gottlieb, M.D., said he will delay issuing layoff notices until after September 30, which is when the agency’s current user fee agreements expire.

Previously, the FDA indicated it could issue layoff notices to thousands of staffers funded by user fees should Congress not act by August 1.

In the email, Gottlieb said he is optimistic the Senate will take up the matter soon and the agency can “reasonably expect” reauthorization to occur before the September 30 deadline. Continue reading

Trump Administration Seeks to Hike Life Sciences Industry’s FDA User Fees Paid to Help Review, Approve Medical Advancements

Washington, DC, April 20, 2017 — Thomas M. Burton reported in The Wall Street Journal that a bipartisan bill in Congress calls for sharp increases in user fees paid by medical industries to the Food and Drug Administration (FDA) to bear the cost of reviewing brand-name and generic drugs, medical devices and a type of generics called biosimilars.

The total base fees for prescription drugs to be collected for fiscal year 2018 under the legislation would be about $878.8 million, up 22% from the current fiscal year’s amount of $718.7 million, according to congressional aides.

The payments from industry have previously accounted for 70% of the FDA’s brand-name drug review budget, 36% of the medical device review budget, 75% of the budget for generic drug reviews and 29% of that for biosimilars, which mimic complex biological drugs. Continue reading