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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

FDA vs. Pentagon: U.S. House Passes Fix to Defense Bill’s Drug Approval Provision

Washington, DC, November 17, 2017 — Rebecca Kheel reports in The Hill that the U.S. House on Wednesday, November 15 passed by voice vote a bill to speed up Food and Drug Administration (FDA) approval of medical devices and drugs to be used on the battlefield.

The bill is meant to address a controversial provision of the annual defense policy bill passed by the House on Tuesday that would allow the Pentagon to sign off on unapproved devices and drugs.

“Our men and women in uniform have put their lives on the line for this country, and they deserve to have the earliest possible access to medical products that could save their lives on the battlefield,” Energy and Commerce Committee Chairman Greg Walden (R-Ore.) said on the House floor Wednesday. “We found a good balance with our friends on the Armed Services Committee, and in working with the FDA and the leadership of the Pentagon.” Continue reading

Controversy Erupts Over Congressional Plan to Let Pentagon Bypass FDA and OK Unapproved Drugs for Battlefield Use

Washington, DC, November 10, 2017 — Should the Pentagon be allowed to authorize the use of unapproved drugs and medical devices on an emergency basis for combat soldiers?

That question, Laurie McGinley reports in The Washington Post, has sparked a furious battle this week among some of Washington’s biggest power players, with the Defense Department and its congressional advocates on one side and the Food and Drug Administration (FDA) and the health committees on the other.

The Capitol Hill clash was set off by a provision in the annual defense authorization bill. Continue reading

FDA Commissioner Says His Agency — Not Defense Department — Should Control Drug and Medical Device Approvals

FDA Commissioner Scott Gottlieb, M.D.

Washington, DC, November 8, 2017 — Rachel Roubein reports in The Hill that Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., said the agency should retain control over medical device and drug approvals after a provision in the defense policy bill would give this power to the Defense Department for soldiers.

Speaking a Tuesday event on opioid prevention sponsored by The Hill and the Pharmaceutical Care Management Association. Gottlieb pointed to an alternative proposal he supports that, he said, would accelerate drug and device approvals at the FDA for the battlefield. 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 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