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Written by Jonathan Wozniak - Validation Specialist, QPharma
Last Valentine’s Day (14 Feb 2011) saw the release of the United States Federal Budget for Fiscal Year (FY) 2012. Included in this was a $4.4 billion budget request for the FDA. This request represents an increase of approximately $1billion or 33% since 2010. Budget proposals include increased investment in food safety initiatives, medical product safety, and regulatory science. This announcement came mere days after House Republicans unveiled a spending bill that included a $241 million cut to FDA funding for the remainder of FY2011 as part of a $100 billion overall spending cut package. The case for or against a strong FDA, however, does not divide clearly down party lines. As professionals in an industry directly regulated, guided, and affected by the strength of the FDA, we are right to wonder: who wants a strong FDA?
In March 2011, the Alliance for a Stronger FDA (an “alliance of patient groups, consumer advocates, biomedical research advocates, health professionals, and trade associations”) released a white paper entitled “The U.S. Food and Drug Administration: A Cornerstone of America’s Economic Future.” (http://fdaalliance.files.wordpress.com/2009/11/fda_cornerstone_of_american_economy_final.pdf)
The second argument suggests that a better-funded FDA will have more, better-trained employees (the FY2012 Budget Request claims 1,251 new employees could be hired). This will expedite approval times and increase the frequency and effectiveness of inspections. For example, the FDA has a two year backlog of generic drug applications due to funding restraints. Better FDA funding means more employees tackling this paperwork. This could result in an increased availability of generic drugs, which saves the consumer money and decreases overall health care spending in America. The Healthcare Reform Act passed last year (H.R. 3590) also included a provision to remove the cap on members of the National Health Service Officer Corp and increase the National Health Service Corp budget by over $8 billion between 2010 and 2016. This would increase the size and reach of the American public health response, but the program- like most current spending initiatives- is now in question. The Alliance also points to the potential consequences of a weakened FDA, namely the increased potential for food borne illness outbreaks and increased frequency of drug and device recalls.
The FDA makes a number of strong claims to its effectiveness and importance: it creates jobs, increases safety and effectiveness of drugs and devices, increases consumer confidence fueling industry growth, and reduces health care costs.
However, the FDA is not without its critics. There are many who believe the FDA is actually too strong, as it is. The first major criticism is that raised by Republican spending cuts: people everywhere have to tighten their belts in difficult economic times; the government should have to do the same. Increases in FDA funding are not necessary, critics claim, because the system works fine as it is. Increased spending on food safety is unnecessary as food borne illnesses are rare. This is, generally speaking, the argument that a strong FDA costs too much. Rep. Jack Kingston, Chairman of the House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, commented after the passage of the Food Safety Bill in January, “There is a high possibility of trimming this whole package back… the system we have is doing a darn good job.” He also noted our food safety rate is “very high, 99.99% safe”. (http://www.foodsafetynews.com/2011/01/fda-food-safety-funding-still-on-chopping-block/)
The second major criticism of a strong FDA is that industry growth is actually stifled. There were only 21 new drugs approved in 2010 (by 21 separate companies). Extra clinical trials, extended review processes, and comparative effectiveness studies are just a few of the measures implemented by the FDA that actually deter companies from new product development. The measures designed to increase safety and improve patient outcomes inherently delay approvals, and these delays cost time, money, and lives. The potential stagnation of innovation in the industry creates opportunities for foreign markets to catch up to the American pharmaceutical and medical device industries moving jobs and revenue overseas.
Meanwhile, FDA faces major statutory initiatives to introduce generic biologics and to require premarket clearance of tobacco products; lack of sufficient personnel to execute these programs could result in their getting shelved, or alternatively, firms facing endless delays; these two alternatives will definitely make some people happier than others, but will increase uncertainty no matter who winds up the winner.
So where should we stand? As professionals in the industry it remains hard to say and might actually vary depending where we work. Drug and device makers might appreciate a weakened FDA in the short term. Inspections, warning letters, and sanctions would be fewer and farther between. Pre-market approval processes could be restructured to facilitate new product release. Drugs not subject to strict comparative effectiveness studies will remain on the market longer. These parties, however, should not forget that approvals may take longer in an understaffed agency, and the potential for recalls increases with an expedited approval process. (http://www.latimes.com/health/la-na-medical-devices-20110215,0,4206876.story)
As a consulting firm dealing largely in compliance and regulation, it would seem on the surface that a more active and involved FDA would create more work for us. The more inspections, rulings, warning letters, and white papers- the more work there is for us helping our clients comply. We would not be shortsighted, however, and ignore the possibility that a strengthened FDA could stifle industry. After all, a company not making money is not hiring consultants.
As experts in industry, we have a responsibility to keep an eye on the strength of the FDA – especially in a time of complicated economic turmoil and incremental health care overhaul. We can help our companies position themselves better for change when we are able to anticipate shifts in the strength of the FDA as a regulating body and what they will mean for industry. A large part of our doing business—from staffing, to setting rates, to training—depends on where and how we anticipate the FDA to act; while the strength of the FDA, predicated by its funding and staffing, largely determines its reach and impact.
Last Valentine’s Day (14 Feb 2011) saw the release of the United States Federal Budget for Fiscal Year (FY) 2012. Included in this was a $4.4 billion budget request for the FDA. This request represents an increase of approximately $1billion or 33% since 2010. Budget proposals include increased investment in food safety initiatives, medical product safety, and regulatory science. This announcement came mere days after House Republicans unveiled a spending bill that included a $241 million cut to FDA funding for the remainder of FY2011 as part of a $100 billion overall spending cut package. The case for or against a strong FDA, however, does not divide clearly down party lines. As professionals in an industry directly regulated, guided, and affected by the strength of the FDA, we are right to wonder: who wants a strong FDA?
In March 2011, the Alliance for a Stronger FDA (an “alliance of patient groups, consumer advocates, biomedical research advocates, health professionals, and trade associations”) released a white paper entitled “The U.S. Food and Drug Administration: A Cornerstone of America’s Economic Future.” (http://fdaalliance.files.wordpress.com/2009/11/fda_cornerstone_of_american_economy_final.pdf)
In this report, the Alliance outlines a number of ways in which the FDA is critical to the future of economic growth. The first main argument put forth in the paper is, roughly, this:
- A strong FDA increases the safety and effectiveness of drugs and medical devices.
- Increased safety and effectiveness of drugs and medical devices increases consumer confidence.
- Increased consumer confidence fuels the industry; people buy more products from an industry they trust.
The FDA makes a number of strong claims to its effectiveness and importance: it creates jobs, increases safety and effectiveness of drugs and devices, increases consumer confidence fueling industry growth, and reduces health care costs.
However, the FDA is not without its critics. There are many who believe the FDA is actually too strong, as it is. The first major criticism is that raised by Republican spending cuts: people everywhere have to tighten their belts in difficult economic times; the government should have to do the same. Increases in FDA funding are not necessary, critics claim, because the system works fine as it is. Increased spending on food safety is unnecessary as food borne illnesses are rare. This is, generally speaking, the argument that a strong FDA costs too much. Rep. Jack Kingston, Chairman of the House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, commented after the passage of the Food Safety Bill in January, “There is a high possibility of trimming this whole package back… the system we have is doing a darn good job.” He also noted our food safety rate is “very high, 99.99% safe”. (http://www.foodsafetynews.com/2011/01/fda-food-safety-funding-still-on-chopping-block/)
The second major criticism of a strong FDA is that industry growth is actually stifled. There were only 21 new drugs approved in 2010 (by 21 separate companies). Extra clinical trials, extended review processes, and comparative effectiveness studies are just a few of the measures implemented by the FDA that actually deter companies from new product development. The measures designed to increase safety and improve patient outcomes inherently delay approvals, and these delays cost time, money, and lives. The potential stagnation of innovation in the industry creates opportunities for foreign markets to catch up to the American pharmaceutical and medical device industries moving jobs and revenue overseas.
Meanwhile, FDA faces major statutory initiatives to introduce generic biologics and to require premarket clearance of tobacco products; lack of sufficient personnel to execute these programs could result in their getting shelved, or alternatively, firms facing endless delays; these two alternatives will definitely make some people happier than others, but will increase uncertainty no matter who winds up the winner.
So where should we stand? As professionals in the industry it remains hard to say and might actually vary depending where we work. Drug and device makers might appreciate a weakened FDA in the short term. Inspections, warning letters, and sanctions would be fewer and farther between. Pre-market approval processes could be restructured to facilitate new product release. Drugs not subject to strict comparative effectiveness studies will remain on the market longer. These parties, however, should not forget that approvals may take longer in an understaffed agency, and the potential for recalls increases with an expedited approval process. (http://www.latimes.com/health/la-na-medical-devices-20110215,0,4206876.story)
As a consulting firm dealing largely in compliance and regulation, it would seem on the surface that a more active and involved FDA would create more work for us. The more inspections, rulings, warning letters, and white papers- the more work there is for us helping our clients comply. We would not be shortsighted, however, and ignore the possibility that a strengthened FDA could stifle industry. After all, a company not making money is not hiring consultants.
As experts in industry, we have a responsibility to keep an eye on the strength of the FDA – especially in a time of complicated economic turmoil and incremental health care overhaul. We can help our companies position themselves better for change when we are able to anticipate shifts in the strength of the FDA as a regulating body and what they will mean for industry. A large part of our doing business—from staffing, to setting rates, to training—depends on where and how we anticipate the FDA to act; while the strength of the FDA, predicated by its funding and staffing, largely determines its reach and impact.
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