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.

Choose NJ’s RFP Watch

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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Food and Drug Administration (FDA)

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

U.S. Senate’s ‘Right to Try’ Bill Could Face Slower Action in House

Washington, DC, August 15, 2017Roll Call reports that a U.S. Senate-passed “right to try” bill that is intended to help dying patients access experimental drugs, which have yet to receive Food and Drug Administration (FDA), likely will face lengthier deliberations in the U.S. House of Representatives.

While the Senate fast-tracked the bill on August 3, the House will likely subject it to a hearing and markup before bringing it up to a vote, according to congressional aides and a lobbyist.

The bill would reduce some of the paperwork involved in getting access to experimental treatments, and would offer protections to the drug companies who choose to make drugs available outside of a clinical trial. Continue reading

STAT: FDA Puts New Restrictions on Hiring of Foreign Scientists, Documents Show

Washington, DC, August 14, 2017 — Erin Mershon reports on STAT that the Food and Drug Administration (FDA) is implementing a new hiring protocol that could make it significantly harder for foreign scientists to find jobs and research opportunities at the agency, according to interviews and newly obtained documents.

Mershon reports that the FDA recently began directing hiring managers not to extend any employment offers — including for fellowship and contractor positions — to any individual who has not lived in the U.S. for at least three of the five previous years, according to briefing materials shared with STAT that have been presented to some agency employees. 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

U.S. Senate Passes Bill to Improve Cancer Drugs for Children

Washington, DC, August 7, 2017 — Ledyard King reports in USA Today that, until now, drug companies have been free to decide whether to pursue treatments for pediatric cancers as part of their work on adult cancers.

They won’t have much choice going forward.

The Senate on August 3 overwhelmingly passed legislation requiring the pharmaceutical industry to expend more resources on treatment for childhood cancers. Continue reading

U.S. Senate Passes ‘Right to Try’ Bill to Help Terminally Ill Patients Access Experimental Drugs

Washington, DC, August 3, 2017 — Laurie McGinley reports in The Washington Post that the United States Senate today passed by unanimous consent a measure designed to make it easier for terminally ill patients to get access to experimental treatments without oversight from the Food and Drug Administration.

The “right-to-try” legislation has been championed by the libertarian Goldwater Institute, which has worked to pass similar legislation in 37 states.

The federal version, now headed to the House, would bar the government from blocking patients from getting access to medications that have undergone only preliminary testing in humans. 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

FDA Commissioner Gottlieb Ends Trump’s Hiring Freeze at Agency

Washington, DC, June 7, 2017 — Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., has pulled the plug on the hiring freeze President Donald Trump imposed on the agency.

The moves will allow the FDA to fill vacancies to shape an agency capable of enacting his plans for how safety and efficacy information are gathered during development. Continue reading

Trump Budget Proposes Deep Cuts to Medical Research and Health Care

Washington, DC, May 24, 2017 — Alison Kodjak and Rob Stein report on NPR that President Donald J. Trump’s proposed budget unveiled Tuesday doubles down on major cuts to biomedical research, programs to fight infectious disease outbreaks, health care for the poor, elderly and disabled, and prevention of HIV/AIDS.

The 2018 budget, which is entitled “A New Foundation for American Greatness,” restates the goals of the “skinny budget” the administration released in March, which was widely condemned by scientists and public health advocates. Continue reading

Senate Confirms Dr. Scott Gottlieb to Head FDA with 57-42 Vote

Dr. Scott Gottlieb

Washington, DC, May 10, 2017 — The Senate voted 57 to 42 on Tuesday to confirm Dr. Scott Gottlieb as commissioner of the Food and Drug Administration (FDA), where he will be responsible for regulating drug companies to which he has had close ties in recent years.

Senators Robert Menendez (D-NJ) and Cory Booker (D-NJ) voted against Dr. Gottlieb’s nomination.

Dr. Gottlieb, 44, has promised to divest himself from several health care companies and recuse himself for one year from decisions involving those businesses. Continue reading