Alliance for a Stronger FDA
- Web site: www.strengthenfda.org
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About Stronger FDA
The Alliance for a Stronger FDA unites a broad group of patient groups, consumer advocates, biomedical research advocates health professionals and industry to work to increase FDA's appropriations. It is supported by leading public health advocates, including three former HHS Secretaries and seven FDA Commissioners. The Alliance is designed to be a multi-year effort to (1) assure the FDA has sufficient resources to protect patients and consumers and (2) maintain public confidence and trust in the FDA.
News and Items of Interest
Wednesday December 10, 2014
Luncheon Briefing On Dietary Guidelines for Americans: Requirements, Challenges and Solutions
Friday Update for October 18, 2013
- Everything Back To Normal? Not Really. FDA employees are working again because the shutdown is over. This is good. However, the situation is far from normal.
- There is the backlog of twelve working days. It’s a lot to miss. Catching up will be difficult, especially while new work is coming in at an even faster clip because of the delays.
- FDA can only spend at the FY 13 post-sequester level, far less than the amount it had to run comparable programs in FY 12 and not reflecting new responsibilities.
- Nothing of any lasting value was accomplished. We hope that a new shutdown can be avoided in January, but our hopes rest on a new spirit of compromise that has yet to appear.
- How does the CR Impact FDA Appropriations? The Continuing Resolution passed by Congress on Wednesday was a slimmed down version of dozens of provisions that have circulated as possibilities over the last four weeks. The key sections: extend government funding through January 15, 2014; suspend the debt limit until February 7, 2014; and require income verification to qualify for premium and cost-sharing subsidies under the Affordable Care Act.
Government funding under the CR is limited to what was available in FY 13 at the post-rescission, post-sequester level. For FDA, this means appropriations spending at the rate of $2.386 billion annually. This is about $120 million less than the agency spent in FY 12. That comes to $10 million per month less under the CR. Programs that were pinched or left short-handed in FY 13 will have to continue that way at least until mid-January.
- How does the CR Impact FDA User Fee’s? With regard to user fees, we have been advised by FDA as follows: “FDA will assess and collect all user fees at the FY 2014 authorized rates during the period of the Continuing Resolution. Consistent with FDA’s FY 2013 annual appropriation, the Continuing Resolution for FY 2014 allows FDA to spend the full amount of actual fee collections – even if those actual collections exceed the spending limits in the FY 13 appropriations bill.”
- How does the shutdown impact FDA User Fee Goals? FDA has provided the following general statement: “FDA has received numerous inquiries about whether the government shutdown will result in missing any of the goal dates established under the various medical product user fee programs. As the agency previously indicated, during the shutdown certain user fee program work continued using carryover funds collected in FY 2013. For this reason, the agency does not, as a general matter, expect that goal dates will be missed as result of the shutdown.”
“For the biosimilar biological products program, for which carryover funds were not available during the shutdown, the agency plans to extend the existing goal dates by the number of days the government was shut down. Even so, because of the need to reschedule certain internal meetings or meetings with product sponsors, some biosimilars goal dates may not be met.”
- Sequestration: Impact Uncertain. The Continuing Resolution’s expiration was intentionally set for January 15, before sequestration cuts would be implemented later in January. Democrats generally favor a higher spending level than the CR and want to negate sequestration for at least FY 14. Republicans generally favor a lower aggregate spending level than the CR, thereby avoiding sequestration. Failing that, they would want sequestration to be imposed to bring spending down and would permit agencies greater flexibility in allocating cuts.
If the current CR’s spending level were to be extended to the whole year, sequestration would require $20 billion in cuts. Under current law, all of that would come from defense and none from non-defense programs. This is explained here. Nonetheless, this is not a good outcome for FDA because both the House and Senate Agriculture appropriations bills for FY 14 would have funded FDA at levels significantly above the FY 13 post-sequester level.
- Alliance to Discuss FDA Funding on BioCentury This Week Television. Steven Grossman, Alliance for a Stronger FDA Deputy Executive Director, will be featured on BioCentury This Week television on Sunday to discuss the consequences of the shutdown and sequestration on FDA as well as prospects for the agency’s budget increases. The program will be broadcast in Washington on WUSA, channel 9, at 8:30am and will be available online starting at 9am. For more details on the program please click here.
Analysis and Commentary
I concluded last week’s column with the following thought:
The shutdown will end, we just don’t know when. At that point, FDA will have a huge backlog of work to do, but everyone will sigh with relief. However, the Alliance has not lost sight of—nor should you—that the continued underfunding of FDA has dire consequences. After the tears of the shutdown, that is still the main story.
Who needs to get that message? First will be the new House/Senate committee set up to work on a path forward on spending and deficits and report back by mid-December. While their job is ostensibly to resolve the $90 billion difference between the House and the Senate budget resolutions, that topic can’t really be addressed without considering sequestration, entitlements and government revenue. Perhaps it is good that the participants themselves, barely a day into the process, have already met once and said publicly how difficult it will be to find middle ground. Realistic expectations may be more fruitful than the optimism that surrounded last year’s super-committee effort to work out budget and deficit issues.
Meantime, the appropriators have been very positive about funding FDA. It is one of few non-defense programs that would receive more money under both the House and the Senate agriculture appropriations bill…than it will under the CR. We will be reaching out to thank them again for their support and remind them that FDA is at a huge disadvantage under the CR.
Authorizers have also been supportive of FDA’s resource needs. They recognize that the multiple pieces of FDA legislation enacted over the last 3 years can’t be implemented without FDA receiving additional resources. Although they don’t have jurisdiction over FDA funding, they are credible voices acknowledging the funding needs.
Finally, the media and the public need to understand that FDA is a part of every American’s life. When you consider food, medication, devices, dietary supplements, pet food and drugs….most people are touched by the FDA every day, often a dozen times or more. The agency is not an optional part of government, but rather is critical to the fabric of life and commerce. As reporters and citizen’s understand this, they can appreciate that it takes manpower (and therefore money) to have the benefits of innovation and the assurance of safety.
This has been a tumultuous couple of weeks. Now we have no option but to dust ourselves off and re-join the long fight for more resources for FDA.
Analysis and Commentary is written by Steven Grossman, the Alliance’s Deputy Executive Director.
Alliance for a Stronger FDA Contacts:
This document is distributed for informational use only; it does not constitute legal advice and should not be used as such.
© 2012 ALLIANCE FOR A STRONGER FDA
Testimony of Diane E. Dorman
President, Alliance for a Stronger FDA
Science Board of the U.S. Food and Drug Administration
February 27, 2013
Good afternoon and thank you for the opportunity to address the FDA Science Board.
My name is Diane Dorman and I am President of the Alliance for a Stronger FDA, as well as Vice President for Policy at the National Organization for Rare Disorders. The Alliance is a 200-member coalition of all FDA’s stakeholders—consumers, patients, health professionals, trade groups and industry. Our sole purpose is to advocate for increased appropriated resources for the FDA.
When we started in 2006, FDA appropriations stood at slightly less than $1.5 billion for an agency tasked with overseeing 100% of drugs, vaccines, medical devices, and personal care products and 80% of our nation’s food supply. Altogether, the products and industries regulated by FDA account for nearly 25% of all consumer spending in the United States.
In short, FDA was the victim of decades of underfunding. It was quite small, despite its vital, complex world-wide responsibilities. Presidents weren’t asking for nearly enough money for FDA and Members of Congress were responding by giving the bare appropriations that had been asked for.
The Alliance’s goal was to change this situation by galvanizing the FDA’s broad stakeholder community to focus attention on the consequences of underfunding. We never doubted the accuracy of our analysis or the importance of our cause.
Nonetheless, it was immensely helpful when--18 months after our founding--the FDA Science Board released its own report in November 2007. As the media described it---the FDA’s own Science Board evaluated the agency’s capacities and responsibilities and declared that the agency’s mission was “at risk.” The word “crisis” was often used and was an appropriate description of the situation.
Subsequently—and with the Alliance’s broad stakeholder advocacy—the prospects for FDA improved. Policymakers acknowledged the underfunding and acted aggressively to reverse it.
Today, in FY 13, the FDA receives slightly more than $2.5 billion in appropriated funding. This amount, might have met the FDA’s funding needs in late 2007 when the Science Board report was issued…BUT NOT NOW.
Today, $2.5 billion is dramatically less than the amount the FDA needs. For reasons I will describe in my testimony, the agency’s mission is again “at risk.” Even without the possibility of funding cutbacks, the American people will lose if FDA does not receive increased funding.
FDA Responsibilities Grow Each Year Because Congress Enacts New Laws
Two months before the Science Board declared FDA to be “an agency at risk,” the FDA Amendments Act of 2007 was signed into law, renewing the prescription drug and medical device user fee programs. It added a slew of new responsibilities, notably in food and drug safety, regulatory science, clinical trial registries, and establishment of a program for risk evaluation and mitigation strategies for new drugs.
The new responsibilities--combined with delays in funding of existing and new programming--had severe consequences. For example, FDA’s efforts in the critical area of drug reviews and approvals were slowed substantially for nearly two years, as demonstrated by this CDER chart.
The message from this experience is clear, albeit not surprising: new laws take enormous resources to implement. Once implemented, they permanently increase agency responsibilities.
Since 2007, Congress has identified a number of new needs that fall within FDA’s jurisdiction. At least six new laws have been passed in the intervening five years:
- Family Smoking Prevention and Tobacco Control Act (2009)
- Biologics Price Competition and Innovation Act (2010)
- Secure and Responsible Drug Disposal Act (2010)
- Combat Methamphetamine Enhancement Act (2010)
- Food Safety Modernization Act (2011), and
- FDA Safety and Innovation Act (2012), including re-authorization of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act
This is hardly the end of it. Congress is already looking at a number of legislative initiatives for 2013, covering topics such as:
- Track and trace/counterfeit products,
- Drug compounding, and
- Drug shortages.
In addition, this year’s legislative requirement--renewal of two Animal Drug User Fees--is widely seen as a vehicle for other legislative mandates that FDA will need to implement.
The problem is not solely Congress’ urge to legislate. While some of our Alliance members may quibble with some of the new programs and requirements, overall I believe there is strong public and stakeholder support for Congress addressing unmet needs and emerging challenges. We all want safe foods and safe and effective medical products.
Ultimately, the real problem is Congress’ failure to acknowledge FDA as a funding priority despite the austere budget environment. Transforming FDA’s mission and responsibilities needs to be met by the necessary resources to do the job well. The current appropriations level is totally inadequate to make up for decades of underfunding AND all of the new laws enacted since 2007.
FDA Responsibilities Grow Each Year Because of Globalization and Scientific Complexity
Even were Congress not active in legislating new mandates for FDA, the agency’s mission and responsibilities would grow enormously each year for reasons unrelated to new laws. While the list is long, my remarks will concentrate on two: globalization and increasing scientific complexity.
One of FDA’s highest priorities since the Science Board report has been to re-align to adjust for the accelerating globalization in all product categories overseen by the agency. While there is no one way to fully convey the enormity of this shift and the resources required, I offer the following sample of key facts:
- Food Imports are growing 10% annually. Altogether, 10-15% of all food consumed in the U.S. is imported. This includes nearly 2/3 of fruits and vegetables and 80% of seafood.
- Device Imports are also growing about 10% annually. Currently, about 50% of all medical devices used in the US are imported.
- Drug Imports are growing even more quickly, about 13% annually. Approximately 80% of active pharmaceutical ingredients (API) are manufactured abroad, as are 40% of finished drugs.
Inspections at U.S. ports-of-entry are critical, but ultimately less than 2% of shipments can be inspected. The better alternative--the one encouraged by Congress and chosen by FDA--is to increase foreign inspections and to establish foreign offices to work globally to improve the standards and quality of products entering the U.S.
The value of this approach cannot really be quantified. We know that the cost of illness, death and lost markets--from just a single bad actor in a single food category--can cost as much or more than the entire investment we put into FDA’s food safety activities. Drugs and devices are harder to track for a variety of reasons, but there is no reason to doubt a similar effect.
In contrast to globalization, greater scientific complexity is diffused into every part of the agency and its mission. That makes dealing with it less visible, but doesn’t make it any less costly.
FDA has adopted several approaches, many from the FDA Science Board Report. These include creation of a commissioner-level science office, investment in regulatory science, expanded and more intensive training, changes in time and manpower allotments for complex assignments, and significant reworking of the drug and medical device approval pathways.
Specifically, we have identified five areas that FDA is working on to improve the review process and respond to more complex science. Each comes at a cost in additional dollars and manpower:
- Sponsors Need More Meeting Time and Other Feedback from FDA
- Product Applications Require More Patients, Study Sites and Analysis
- Enhanced Timeliness and Consistency of Product Review is Paramount
- Expansion of Pre-and Post-Market Safety is Essential
- Sustain and Increase Core Programs That Enhance Innovation, Speed Approvals
Further, safety inspections have also become more complex—requiring more scientific training, more preparation and, often, more time during the inspection itself.
FDA: An Agency Still Very Much “At-Risk” for Lack of Adequate Fundin
It is important to recollect that FDA is a staff-intensive organization. More than 80% of its budget is devoted to staff-related costs. Of the remainder, rent and utilities are fixed costs that must be paid first. There is little grant and contracting to cut.
Sequestration is the most immediate threat to the FDA’s already-inadequate funding. Just a few days from now, the agency faces a loss of 5.1% of its FY 13 (current year) budget. This is the nominal rate. The Alliance’s analysis, confirmed by OMB testimony, is that the actual impact will be close to 9%.
Even if sequestration is avoided, FDA faces challenging funding battles in FY 14 and beyond.
If cuts occur now or in FY 14—or even if the agency budget stalls and fails to grow over the next few years:
- food will be less safe and consumers put at risk,
- drug and device reviews will be slower, conflicting with promises made to consumers and companies,
- problems with imports and globalization will become more numerous, and
- critical efforts to modernize the agency and improve its support for innovation will stall.
Is FDA’s mission again at risk? Absolutely, yes.
And those who have the most to lose are the American people
Alliance Recognizes Imperative for Budget-Cutting; Views FDA as an Exception
WASHINGTON, D.C., February 9, 2011 – The Alliance for a Stronger FDA today responded with concern to the House Appropriations Committee’s announcement of cuts to FDA that will be included in that body’s FY 11 Continuing Resolution (CR). The CR will be considered on the House floor next week.
“Our nation needs an effective FDA, which requires continuing increases for an agency that has been chronically underfunded for several decades,” said Nancy Bradish Myers, President of the Alliance for a Stronger FDA and President of Catalyst Healthcare Consulting. “We certainly understand the need to reduce the federal budget, but want to be sure that Congress has a clear picture of how FDA contributes to economic growth and national security, as well as protecting our public health.”
The committee is proposing that FDA be cut by $220 million below the President’s request level for FY 11. The amount is about $74 million less than FY 10 funding, which is the level at which the agency has received and spent funds thus far in FY 11.
“FDA touches every American multiple times each day through its jurisdiction over drugs, biologics, medical devices, 80 % of the food supply, cosmetics, dietary supplements and varied consumer products. Altogether, the agency oversees nearly 25% of consumer spending in the United States,” said Margaret Anderson, Vice President of the Alliance and Executive Director of FasterCures. “FDA funding should reflect that the agency’s responsibilities and workload increase each year--through globalization, scientific complexity, and the growth of industry, as well as through new mandates.”
Ms. Myers added: “Today’s investment of 2 cents per American per day is small compared to the benefits of a strong FDA and the risks from an underfunded FDA. We look forward to working further with Congress to be sure that the needs of the American people are being met.”
The Alliance’s 180 (and growing) membership is comprised of consumer, patient, professional and research groups, companies, trade associations, and individuals who support increased appropriated funding for FDA. The Alliance is the only multi-stakeholder group that advocates for increasing resources at FDA to match the agency’s responsibilities.
More information about the Alliance can be found at www.StrengthenFDA.org.
Alliance for a Stronger FDA "Disappointed"
By President’s FY 11 Budget Request for FDA
Three Years of Above-Inflation Increases Have Not Offset the Impact of a Decade of Neglect
WASHINGTON, D.C., February 2, 2010 –While acknowledging that the U.S. Food and Drug Administration (FDA) received a budget increase while many federal agencies did not, the Alliance for a Stronger FDA today expressed disappointment with President Obama’s FY 11 funding request for FDA The President’s request is for an increase of $146 million, which would bring FDA's appropriated funding to $2.508 billion (see attached chart).
The Alliance said the President’s request is consistent with the amount by which FDA’s costs increase each year. It will sustain FDA’s current programming and personnel in FY 11. It will not enable FDA to add necessary new programs or personnel.
"We are grateful that the President has proposed an inflationary increase of about 6 percent for FDA in a year in which most domestic discretionary programs will be frozen or cut," said Wayne Pines, President of the Alliance.
"However, the FDA needs a real increase if it is to establish needed new programs and hire new people to carry them out. The American people must rely on FDA to assure the safety of products that constitute 25 cents of every consumer dollar spent. Continuing chronic underfunding of FDA affects our public health, our economy and our national security."
Pines added: "We are disappointed in the President’s budget request and our Alliance will seek to work with the Congress and the Administration to increase FDA’s budget for FY 2011 beyond a simple inflation increase. We will have the support of our entire membership in this goal."
The Alliance for a Stronger FDA is a coalition of more than 180 consumer, patient, professional and research groups, companies, trade associations, and individuals who support increased appropriated funding for FDA. The Alliance is the only multi-stakeholder group that advocates for increasing resources at FDA to match the agency’s responsibilities.
"Even with funding increases over the last three years, FDA’s appropriation in FY 10 supported about the same number of full-time employees as 1994, a time period in which FDA faced fewer challenges in both number and complexity," said Nancy Bradish Myers, Vice President of the Alliance and President of Catalyst Healthcare Consulting. "A larger financial investment is necessary to help alleviate the agency’s severe resource constraints caused by years of chronic underfunding and a rapidly growing list of complex public health challenges."
The erosion of FDA’s budget has coincided with a time in which the agency's workload has soared to include major public health initiatives such as H1N1 influenza, bioterrorism, and the inspection of an unprecedented amount of food and medical products from around the globe. "The imbalance between FDA’s funding and its expanding portfolio of public health responsibilities has left the agency overextended and ill equipped to effectively carry out its mission as the world's premier protector of public health," Pines said.
"Currently, FDA lacks the regulatory tools, expertise and processes to help spur the development of life-saving therapies from emerging biomedical fields such as stem cells and personalized medicine," said Dan Perry, an Alliance board member and Executive Director of the Alliance for Aging research. "Our broad and diverse Alliance of more than 180 members looks forward to ensuring that policymakers are apprised of FDA's need for consistent multi-year budget increases to bring FDA’s scientific and regulatory capacities up to speed with these sophisticated new areas."
"We realize that the President is committed to reducing the deficit, including lowering overall government spending," said Caroline Smith DeWaal, an Alliance board members and Food Safety Director at the Center for Science in the Public Interest. "Investments in FDA that prevent foodborne outbreaks and intentional contamination are important to achieving these goals as they reduce overall health care costs and losses to industry."
More information about the Alliance can be found at www.StrengthenFDA.org.