Friday, February 13, 2015

Food and Drug Seeks $4.9 Billion for FY 2016

WASHINGTON, DC (PR) - The U.S. Food and Drug Administration is requesting a budget of $4.9 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2016 budget – a nine percent increase over the enacted budget for  FY 2015. The overall request includes $147.7 million in budget authority for initiatives tied to several key areas, including the implementation of the FDA Food Safety Modernization Act and the management of critical medical products issues.

The FY 2016 budget request reflects the FDA’s commitment to fulfill the mandates of groundbreaking legislation passed in recent years, which has given the agency increased regulatory responsibilities. The FDA’s scope has also expanded as it regulates an ever-increasing number of food and medical products imported from all over the world.

“This budget accurately reflects the challenges FDA faces in a global regulatory environment, which is becoming increasingly complex and scientifically demanding,” said Commissioner Margaret A. Hamburg, M.D. “As FDA’s mission expands on several fronts –– from the regulation of tobacco products to supporting the development of personalized medicine to ushering in a new era of food safety – we must possess the resources to run a modern agency that fosters innovation and ensures the safest possible drug and food supply for the American people.”

Highlights of the FDA FY 2016 budget include:

Implementing a New Food Safety System (+$109.5 million in budget authority): The FDA Food Safety Modernization Act, signed into law by President Obama in 2011, required sweeping changes to the nation’s food safety program to help prevent foodborne illness, resulting in multiple new regulations and a substantial strengthening of the agency’s food inspection capabilities. 

The FY 2016 budget request will allow the FDA to: implement fundamental requirements for domestic food and feed safety; acquire the technical staffing needed to support the law, including the training of new inspectors; provide the appropriate guidance to industry about the changes the law will bring; strengthen the role of the states in helping to ensure the safety of the country’s food supply; and build and implement a new import safety system.

Improving the Safety and Quality of Medical Products (+$33.2 million in budget authority): Medical products regulated by the FDA are crucial to the health of Americans and impact nearly every aspect of medical care in the United States. The FDA’s FY 2016 request seeks to improve safety and quality and support innovation across the entire spectrum of regulated products. 

Key priorities include: combating the growing threat of antibiotic resistance; facilitating the development and appropriate use of reliable molecular and genetic diagnostics – also known as precision medicine tools – to “personalize” the diagnosis and treatment of disease; implementing key requirements of the Food and Drug Administration Safety and Innovation Act; addressing the safety of compounded drugs and medical products; and implementing the Sunscreen Innovation Act.

Building a More Modern FDA (+$5.0 million in budget authority, plus $24.0 million already included in the prior highlights): Five major pieces of groundbreaking legislation passed since 2009 have greatly increased the FDA’s responsibilities. As the agency’s mandate expands, more scientists, doctors, analysts and inspectors are needed to fulfill the FDA’s evolving mission. 

The FDA’s staffing needs must increase by 70 percent by FY 2016, compared to FY 2008. The FDA requires additional funding for rental payments and a feasibility study to update and issue a revised Master Plan for the White Oak campus in order to address its expanded workforce and the facilities needed to accommodate them. 

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.

Risk Communication

FDA is proposing a study which I call “less is more.” The study is long overdue. They are concerned that too many risks are being presented in television ads and perhaps this confuses consumers. The basic lesson of advertising is to focus on the main point or compelling benefit if you want people to remember it. That lesson also applies to risk.

Consumers deserve to know about any significant risk of a drug they are taking or may take. Current DTC ads are risk heavy and loading ads with the many potential risks and side effects obscure what really are the most important. So if something minor happens to one in ten thousand people, is that worthy of being mentioned? 

I have always been an advocate of presenting the odds of serious risk. FDA needs to provide guidance in consumer terms. If I have several friends who got a side effect, then that is worth mentioning. If I have to dig in the medical literature to find the one person having a side effect it is not. FDA is considering doing what any reasonable person would do. That is, discuss risk in the context of its frequency and seriousness.

We do not require auto makers to say you may die driving their car. We do not require airlines to discuss the risk of a crash. Yet drugs seem to be treated as something deserving of the mention of anything that may happen if taken. It is about time consumers were given some better information. If it kills one in a five hundred thousand do I really need to be told that in an ad? 

I hope this study can provide some data that will help. This falls in the category of better late than never. There is, of course, a lot of general literature on advertising recall, and perhaps FDA could make sensible conclusions based on the existing vast history on advertising concepts. That would say consumers watching ads can remember very little, so less is more. 

I know FDA is filled with bright people so I assume they know this concept. What is frustrating is their pace in advancing sensible regulation. By the time they finish this study it will be twenty years since television ads were presented to consumers. If consumers are risk confused now, they were in 1997 as well. FDA has told me numerous times how busy they are, so it is no surprise they are just getting to this study. It is a sad commentary, however, on their staffing and/or their priorities.
I guess we must be thankful FDA took some regulatory liberties and allowed the 60 second ad in 1997. So despite the nearly two decades it took to get here, the study is important for industry and its customers. 

Bob Ehrlich, Chairman
DTC Perspectives, Inc.

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