FDA seeks $5.1 billion total for FY 2017

FDAThe U.S. Food and Drug Administration is requesting a total budget of $5.1 billion to protect and promote the public health as part of the President's fiscal year (FY) 2017 budget - an eight percent increase over the enacted budget for FY 2016. The overall request includes a net increase of $14.6 million in budget authority and $268.7 million in user fees for initiatives tied to several key areas, including the implementation of the FDA Food Safety Modernization Act (FMSA) and efforts to improve medical product safety and quality. The agency is also seeking $75 million in new mandatory funding to support the National Cancer Moonshot initiative being led by the Vice President.

"The FDA continues to work to obtain the most public health value for the federal dollar as we address expanded regulatory responsibilities and scientific challenges," said FDA Acting Commissioner Stephen Ostroff, M.D. "The agency remains fully committed to meeting the needs and high expectations of the American people regarding the products we regulate, as well as advancing the prevention, screening, diagnosis, and treatment of cancer."

The FY 2017 request covers the period from Oct. 1, 2016, through Sept. 30, 2017. Highlights of the FDA FY 2017 budget include (net increases of):

  • Continued Implementation of a New Food Safety System (+$18.4 million in budget authority; +$193.2 million in user fees): The FDA has finalized major rules that implement the core of FSMA, the most sweeping overhaul of the country’s food safety system since the first federal food safety law was passed in 1906. The FY 2017 budget builds on this work by supporting federal and state efforts to establish enforceable safety standards for produce farms. Funding also will enable the FDA to continue progress to hold importers accountable for verifying that imported food meets U.S. safety standards, as well as conduct food safety audits of foreign food facilities.
  • Improving the Safety and Quality of Medical Products (+$3.2 million in budget authority; +$38 million in user fees): The FDA's FY 2017 budget request seeks to improve safety and quality and support innovation across a wide range of regulated medical products that are crucial to the health of Americans and impact nearly every aspect of medical care in the United States. With this request, the FDA will improve medical product safety and availability by: evaluating precision medicine tools to "personalize" the diagnosis and treatment of disease; improving the safety of compounded drugs through sustained or increased inspection and enforcement activities, and policy development; addressing public health safety concerns associated with antimicrobial drug use in animals to better protect antibiotic effectiveness for both human and animal populations; and supporting animal drug and medical device review. These efforts are in concert with other top priorities such as identifying solutions to prevent prescription opioid abuse, speeding the access to safe and effective generic drugs and reducing the number of drug shortages.
  • Supporting the National Cancer Moonshot Initiative (+$75 million in mandatory funding): In order to support the dramatic increase in the number, complexity, and effectiveness of cancer diagnostics and therapeutics, the FDA will develop a virtual Oncology Center of Excellence to leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, and devices. This center will expedite the development of novel combination products and support an integrated approach in: evaluating products for the prevention, screening, diagnosis, and treatment of cancer; supporting the continued development of companion diagnostic tests, and the use of combinations of drugs, biologics and devices to treat cancer; and developing and promoting the use of methods created through the science of precision medicine.
  • Investing in the FDA's Infrastructure (+$3 million in building and facilities funding; +$600,000 in other infrastructure-related funding): The FDA’s responsibilities continue to escalate as the agency works to fulfill the mandates of groundbreaking legislation passed in recent years. This expansion of authorities urgently requires that the FDA’s critical infrastructure at its owned locations is properly functioning to enable the agency to carry out its mission and respond to food safety and medical product emergencies.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Most Popular Now

Top 20 breaking World Pharma News of 2017

We are proud to announce the top 20 most popular breaking World Pharma News from 2017. Have a wonderful 2018 new(s) year filled with health, happiness, and spectacular su...

Novartis advances head-to-head superiority trials …

Novartis announced today the initiation of SURPASS, a head-to-head clinical trial of Cosentyx® (secukinumab) versus proposed biosimilar adalimumab** in ankylosing spondyl...

Roche and Ignyta reach definitive merger agreement

Roche (SIX: RO, ROG; OTCQX: RHHBY) and Ignyta, Inc. (NASDAQ: RXDX) today announced they have entered into a definitive merger agreement for Roche to fully acquire Ignyta ...

Antidepressant may help combat the course of multi…

The antidepressant clomipramine may also alleviate symptoms of multiple sclerosis (MS), specifically in its progressive form, i.e. when it occurs without relapses or remi...

Diabetes drug 'significantly reverses memory loss…

A drug developed for diabetes could be used to treat Alzheimer's after scientists found it "significantly reversed memory loss" in mice through a triple method of action...

FDA updates the label of Tasigna to reflect that c…

The U.S. Food and Drug Administration today updated the product label for the cancer drug Tasigna (nilotonib) to include information for providers about how to discontinu...

Zika remains a research and public health challeng…

Since 2016, when Zika was declared by the World Health Organization as a public health emergency of international concern, the virus has become established in more than 8...

Try exercise to improve memory, thinking

For patients with mild cognitive impairment, don't be surprised if your health care provider prescribes exercise rather than medication. A new guideline for medical pract...

Dirt-dwelling microbe produces potential anti-mela…

A type of soil-dwelling bacterium produces molecules that induce death in melanoma cells, research at Oregon State University shows. The molecule is a secondary metabolit...

Sandoz regulatory submission for proposed biosimil…

Sandoz, a Novartis division and the global leader in biosimilar medicines, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics Licen...

Novartis Kisqali® received FDA Breakthrough Therap…

Novartis today announced Kisqali® (ribociclib) received US Food and Drug Administration (FDA) Breakthrough Therapy designation for initial endocrine-based treatment of pr...

FDA approves first treatment for breast cancer wit…

The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast can...

Pharmaceutical Companies

[ A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Z ]