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)

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

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

FDA and Industry Fear Wave of Medical-Device Hacks

Washington, DC, April 12, 2017 — Casey Harper reports in The Hill that Regulators and medical-device-makers are bracing for an expected barrage of hacking attacks even as legal and technical uncertainties leave them in uncharted territory.

Tens of millions of electronic health records have been compromised in recent years, a number that is growing and, some say, underreported.

 

High-profile attacks have hit hospitals and health insurers, and now attention is turning to a new vulnerability: medical devices like pacemakers and insulin pumps. 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

Former FDA Commissioner Robert Califf Urges Scientific Community to Speak Out Against ‘Ridiculous’ Budget Proposal

Dr. Robert Califf

Washington, DC, April 6, 2017 — Ike Swetlitz reports in STAT that Dr. Robert Califf, the former commissioner of the Food and Drug Administration, on Tuesday called President Trump’s budget blueprint “ridiculous” and implored the scientific community to “speak out against it.”

Califf made the remarks while moderating a panel at a meeting on how clinical trial data should be shared within and beyond the research community.

The two-day meeting was hosted by the New England Journal of Medicine, one of the top peer-reviewed medical journals. Continue reading

Former FDA Commissioners Denounce Drug Importation, Citing Dangers to Consumers

Washington, DC, March 21, 2017 — Laurie McGinley reports in The Washington Post that the four most recent Food and Drug Administration (FDA) commissioners are warning Congress that legalizing the importation of drugs from other countries — an idea that has drawn support from both Bernie Sanders and President Trump — is a risky approach that would endanger consumers by exposing them to fake, substandard and contaminated drugs.

The open letter to members of Congress, which was posted Friday by the Margolis Center for Health Policy at Duke University, was signed by two former FDA heads who served during the Obama administration — Robert Califf and Margaret Hamburg — and two who served under former president George W. Bush — Andrew von Eschenbach and Mark McClellan. 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