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    FDA: All of the Responsibility, but None of the Financial Support?

    Nov. 8, 2007
    paperworkWell, golly, it's just great that our nation's legislators have so much faith in FDA's abilities that they keep asking the Agency to take on additional responsibilities. But consider this: isn't that kind of like a company that promotes individuals to the level of their incompetence? On Tuesday (11/6), Rep. Henry A. Waxman, Sen. Edward M. Kennedy, and Rep. Tom Allen introduced the Non-Prescription Drug Modernization Act, a bill that would "permit FDA to act quickly to protect consumers from unsafe or ineffective over-the-counter (OTC) drugs." The legislators noted that under current law, in order for FDA to ban an OTC drug that the Agency deemed to lack evidence of efficacy or to have the potential for causing harm, it would have to go through a rulemaking process that could take years to complete. According to the bill's sponsors, "The Act would also transfer oversight of OTC drug advertising from the FTC to the FDA, which already regulates the advertising for prescription drugs, and would require FDA to review the current OTC regulatory regime to assess whether it is outdated." (See the Oversight Committee's press release for details.) Okay, I can see how the honorable Messrs. Waxman, Kennedy and Allen could have concluded that if FDA were monitoring both the manufacture and the marketing of OTC drugs, we might not have reached the point where an FDA advisory panel recommended banning OTC cough and cold medications for children under the age of six, but current regulations have hamstrung the Agency. However, as I noted in a previous post, federal funding that could give the Agency legs (to complement its newly acquired teeth) simply hasn't materialized. Those of us in Corporate America have long been acquainted with the exhortation "do more with less," but we don't have Congress, consumer advocacy groups and a population of 300 million breathing down our necks. Nor is it likely that illness or death will result from our actions (or lack thereof). Would Congress expect our forces in Iraq to fulfill their mission with less than half the number of troops deemed necessary? Of course not, but somehow they expect an overextended, underfunded Food and Drug Administration to assume more responsibilities and do a more thorough job of policing the food and pharmaceutical industries. Oh, you need money in order to hire additional staff and modernize your IT infrastructure? No problem -- you can collect fees from the manufacturers whose facilities you inspect. Never mind all those people who think that means you're in the industry's pocket -- they simply don't understand how government works. Don't you worry, Dr. Eschenbach; the Administration thinks you and your staff are "doing a heck of a job." -HP
    paperwork
    Well, golly, it's just great that our nation's legislators have so much faith in FDA's abilities that they keep asking the Agency to take on additional responsibilities. But consider this: isn't that kind of like a company that promotes individuals to the level of their incompetence? On Tuesday (11/6), Rep. Henry A. Waxman, Sen. Edward M. Kennedy, and Rep. Tom Allen introduced the Non-Prescription Drug Modernization Act, a bill that would "permit FDA to act quickly to protect consumers from unsafe or ineffective over-the-counter (OTC) drugs." The legislators noted that under current law, in order for FDA to ban an OTC drug that the Agency deemed to lack evidence of efficacy or to have the potential for causing harm, it would have to go through a rulemaking process that could take years to complete. According to the bill's sponsors, "The Act would also transfer oversight of OTC drug advertising from the FTC to the FDA, which already regulates the advertising for prescription drugs, and would require FDA to review the current OTC regulatory regime to assess whether it is outdated." (See the Oversight Committee's press release for details.) Okay, I can see how the honorable Messrs. Waxman, Kennedy and Allen could have concluded that if FDA were monitoring both the manufacture and the marketing of OTC drugs, we might not have reached the point where an FDA advisory panel recommended banning OTC cough and cold medications for children under the age of six, but current regulations have hamstrung the Agency. However, as I noted in a previous post, federal funding that could give the Agency legs (to complement its newly acquired teeth) simply hasn't materialized. Those of us in Corporate America have long been acquainted with the exhortation "do more with less," but we don't have Congress, consumer advocacy groups and a population of 300 million breathing down our necks. Nor is it likely that illness or death will result from our actions (or lack thereof). Would Congress expect our forces in Iraq to fulfill their mission with less than half the number of troops deemed necessary? Of course not, but somehow they expect an overextended, underfunded Food and Drug Administration to assume more responsibilities and do a more thorough job of policing the food and pharmaceutical industries. Oh, you need money in order to hire additional staff and modernize your IT infrastructure? No problem -- you can collect fees from the manufacturers whose facilities you inspect. Never mind all those people who think that means you're in the industry's pocket -- they simply don't understand how government works. Don't you worry, Dr. Eschenbach; the Administration thinks you and your staff are "doing a heck of a job." -HP
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