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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FDA

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

President Trump Considering Fairleigh Dickinson’s Dr. Joseph Gulfo to Head FDA

Joseph Gulfo, M.D.

Teaneck, NJ, February 6, 2017 — Kelly Heyboer reports in The Star-Ledger that President Donald J. Trump is considering a Fairleigh Dickinson University official, Dr. Joseph Gulfo, who wrote a book critical of the Food and Drug Administration (FDA), is one of President Donald Trump’s top choices to lead the federal agency.

Joseph Gulfo, M.D., executive director of Fairleigh Dickinson’s Lewis Center for Healthcare Innovation and Technology, is one of the names being vetted for the FDA commissioner job, according to the political website The Hill and several pharmaceutical industry publications.

Gulfo did not respond to requests to comment on the reports. Continue reading

President Trump’s FDA Pick Could Undo Decades of Drug Safeguards

Washington, DC, February 6, 2017 — Katie Thomas reports in The New York Times that President Donald J. Trump’s vow to overhaul the Food and Drug Administration (FDA) could bring major changes in policy, including steps to accelerate the process of approving new prescription drugs, setting up a clash with critics who say his push for deregulation might put consumers at risk.

President Trump has been vetting candidates to run the agency, which regulates the safety of everything from drugs and medical devices to food and cosmetics. 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

PhRMA: Three Things to Know About 2016 Drug Approvals

phrma-logo-whiteWashington, DC, January 10, 2017 — PhRMA Director of Public Affairs Andrew Powaleny writes In 2016, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 22 new medicines to treat a broad range of illnesses for patients in need.

These much-needed new treatments include medicines for multiple sclerosis, chronic lymphocytic leukemia, ovarian and bladder cancer and the very rare spinal muscular atrophy (SMA).

Among these new medicines, more than a third are treatments for rare diseases and more than one-third are first-in-class, meaning they use a new, unique approach to treating an illness that has never before been available. Continue reading

Drug Companies Await FDA Guidance on Off-Label Uses of Medicines

FDA blueWashington, DC, December 22, 2016 — Sarah Chacko reports in The Hill that doctors commonly prescribe drugs to treat conditions the medications weren’t designed for, but for drug makers, discussing such “off-label” uses can lead to trouble.

As a result, drug makers have been pushing both the Food and Drug Administration (FDA) and lawmakers to draw clearer lines around communicating about unapproved uses of their products, particularly since it affects what companies can tell insurers.

Such information is used to negotiate prices for covered medical products and their place in certain payment models. Continue reading

Congress Passes 21st Century Cures Act; President Obama Praises Bill to Accelerate Medical Innovation

21st-century-cures-blueWashington, DC, December 8, 2016 — Mike DeBonis reports in The Washington Post that Congress passed sweeping legislation yesterday that boosts funding for medical research, eases the development and approval of experimental treatments and reforms federal policy on mental health care.

The 94 to 5 Senate vote Wednesday followed a 392 to 26 House vote last week.

The bill, known as the 21st Century Cures Act, now heads to the desk of President Obama, who praised the bill Wednesday and said he would sign it. Continue reading

U.S. House Approves 21st Century Cures Bill, A Sweeping Health, Medical Innovation Measure

21st-century-cures-blueWashington, DC, December 1, 2016 — Jennifer Steinhauer and Sabrina Tavernise report in The New York Times that the U.S. House or Representatives yesterday overwhelmingly passed a far-reaching measure — the 21st Century Cures Act — to increase funding for research into cancer and other diseases, address weaknesses in the nation’s mental health systems and help combat the prescription drug addictions that have bedeviled nearly every state.

In a statement, House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO), co-authors of the bill, said, “21st Century Cures is the innovation game-changer that patients, their loved ones, and the nation’s researchers and scientists so desperately need.”

“The White House has expressed its enthusiastic endorsement of this critical legislation,” Upton and DeGette said.  “So it’s now on to the Senate, where we are just one final vote away from delivering #CuresNow.” Continue reading

President-Elect Trump to Nominate Rep. Tom Price to Serve as Health and Human Services Secretary

Rep. Tom Price

Rep. Tom Price

Washington, DC, November 29, 2016 — Robert Pear reports today in The New York Times that President-elect Donald J. Trump has picked Congressman Tom Price, a six-term Republican congressman from Georgia, to be Secretary of Health and Human Services.

Pear reports that if Mr. Trump’s wanted a cabinet secretary who could help him dismantle and replace President Obama’s health care law, the Affordable Care Act or Obamacare, he could not have found anyone more prepared than Rep. Price, who has been studying how to accomplish that goal for more than six years.

Congressman Price, an orthopedic surgeon who represents many of the northern suburbs of Atlanta, speaks with the self-assurance of a doctor about to perform another joint-replacement procedure.  He knows the task and will proceed with brisk efficiency. Continue reading

STAT: Could the FDA Be Dismantled Under President Trump?

STATWashington, DC, November 29, 2016 — Has President-elect Donald Trump put a bull’s-eye on the Food and Drug Administration?

Sheila Kaplan reports on STAT that it’s been less than a year since Dr. Robert Califf was sworn in as the FDA’s chief, but already the agency is facing post-election upheaval.

Public health advocates are bracing for a seismic shift: a surrender of the agency’s rules for off-label promotion of drugs; the importation of more drugs from other countries; and fewer requirements for clinical trials — long the gold standard for determining whether medicines are safe and effective. Continue reading