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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Drug Approval

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 Announces Two Steps to Increase Drug Competition for Improved Patient Access

Washington, DC, August 2, 2017 — The U.S. Food and Drug Administration (FDA) on June 27 announced it is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives.

The agency published a list of off-patent, off-exclusivity branded drugs without approved generics, and also implemented, for the first time, a new policy to expedite the review of generic drug applications where competition is limited.

These actions are among the first taken under the agency’s Drug Competition Action Plan, announced by FDA Commissioner Scott Gottlieb in late May. 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

FDA Approves a Second Drug Is Approved to Treat Lou Gehrig’s Disease

Washington, DC, May 8, 2017The New York Times reports that a new drug for amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease, was approved on May 5 by the Food and Drug Administration (FDA).

The drug, called Radicava or edaravone, slowed the progression of the degenerative disease in a six-month study in Japan.

It must be given by intravenous infusion and will cost $145,524 a year, according to its manufacturer, MT Pharma America, a subsidiary of the Japanese company Mitsubishi Tanabe Pharma Corporation. 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

Study: FDA Approves More Drugs, and Faster, Than Europe

Washington, DC, April 7, 2017 — The Associated Press reports that, contrary to some political claims — including President Donald Trump — the U.S. Food and Drug Administration approved more drugs, and two to three months faster on average, than European regulators did in recent years, new research published Wednesday in the New England Journal of Medicine.

The new research compared how new drugs fared before the FDA and the European Medicines Agency between 2011 and 2015.

The FDA approved more drugs than the Europeans — 170 versus 144 — with a median review time of 306 days versus 383 days in Europe. Continue reading

White House Announces President Trump to Select Dr. Scott Gottlieb to Head FDA

Scott Gottlieb, M.D.

Washington, DC, March 13, 2017 —Laurie McGinley and Carolyn Y. Johnson report in The Washington Post that President Donald J. Trump announced on March 10 that he will nominate Scott Gottlieb, a conservative physician and businessman with deep ties to the pharmaceutical industry, to be commissioner of the Food and Drug Administration.

If confirmed, Gottlieb would bring a strong pro-industry, deregulatory approach to an agency that Trump has criticized as being overly restrictive.

But he is also likely to support one of the agency’s basic functions: to ensure that drugs are proven safe and effective before they are sold. Continue reading

ITIF Report: Timely Congressional Reauthorization of Prescription Drug User Fee Act Is Critical for Biomedical Innovation

Washington, DC, March 6, 2017 — As Congress considers reauthorizing the Prescription Drug User Fee Act (PDUFA) this year, policymakers should recognize the foundational role it plays in America’s biomedical ecosystem by supporting life-sciences innovation and speeding cures, argues the Information Technology and Innovation Foundation (ITIF) in a new report.

“User fees help provide the FDA with the resources necessary to make accurate, timely determinations about the safety and efficacy of new drugs,” said Stephen J. Ezell, ITIF’s vice president for global innovation policy and the report’s author. Continue reading

STAT: PhRMA CEO Says FDA Review Process Is ‘Gold Standard and Should Remain So’

Boston, MA, February 22, 2017 — Rebecca Robbins reports on STAT+ that Stephen Ubl, the President and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA), yesterday came out strongly in favor of a rigorous Food and Drug Administration (FDA).

Ubl’s remarks come as the Trump administration weighs potential candidates to lead the agency who have suggested they would radically change how it vets new drugs.

Asked by STAT about the notion that the FDA should no longer evaluate drugs for effectiveness, Ubl was unambiguous: “We believe that the FDA review process is the gold standard and should remain so.” Continue reading

FDA’s New Drug Approvals in 2016 Fall to Six-Year Low; Europe Approves More Medications

Washington, DC, February 1, 2017 — Reuters last month  reported that 2016 was a disappointing year for new drug approvals with the U.S. Food and Drug Administration (FDA) clearing just 22 new medicines for sale, the lowest number since 2010 and sharply down on 2015’s tally of 45.

Across the Atlantic, the European Medicines Agency recommended 81 new prescription products against a 2015 total of 93.  Unlike the FDA, the EMA includes generic drugs in its list. Continue reading