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CODEX, SUPPLEMENTS, AND AMTA ON CONGRESSIONAL AGENDA
by Lee Bechtel July 2005 |
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Action on health-freedom legislation is taking shape in Congress. Legislators will be considering the issues of whether or not to withdraw the United States from the World Trade Organization and from the Codex process, prescription-drug reimportation, dietary-supplement restrictions in the name of food “safety,” and granting access to medical treatments free of FDA interference.
Codex Legislation
Congressmen Ron Paul (TX-14) and Bernie Sanders (I-VT) introduced House Joint Resolution 27. The bill, in effect, called on the U.S. to withdraw from the Codex Alimentarius (International Food Code) Commission, which is sanctioned under the World Trade Organization (WTO). The NHF and its representative, Scott Tips, have played a long and important role in challenging the decisions and actions of the Codex Commission and its committees over many years. The U.S. representatives to the Commission from the Food and Drug Administration (FDA) have been unresponsive to the complaints of health-freedom and dietary-supplement groups in their participation as a member country. The WTO is a non-transparent, non-accountable organization that regularly votes against the interests of the American people in all spheres of interest. It is particularly galling to see the WTO as the enforcement arm of the Codex, whose soon-to-be-finished "standards" will quickly enough be used to take away our health freedoms here in America. Unfortunately, on June 9, 2005, the House voted on H.J.Res. 27 and rejected the resolution. There were 86 Representatives who did vote for it. This was more support than in the last Congress. I actively lobbied to get Representatives to sign on as sponsors of the bill. The NHF has also sent letters to all 86 Representatives thanking them for their leadership and courage in supporting the legislation.
Tax Deductibility Of Supplements
Two Congressional bills, HR 2486 and HR 1545, have been introduced to treat expenses for certain meal-replacement and dietary-supplement products that qualify for FDA-approved health claims as being tax-deductible medical care costs. This is a long overdue change in IRS tax policy. It is well known that about 158 million people in America take supplements on a regular basis, and that supplements help prevent more serious illnesses. A reduction in healthcare expenditures is of paramount importance to the future economic well being of the country. Americans who are helping to keep healthcare costs down are not allowed to claim the cost of supplements as a medical expense. H.R. 1545 was introduced by Congressman Chris Cannon (UT-3) and has four co-sponsors – Representatives Jeb Bradley (NH-1), John Duncan (TN-2), Ron Paul (TX-14), and Edolphus Towns (NY-10). H.R. 2486 was introduced by Congressman Dan Burton (IN-6) and has a similar number of cosponsors. The NHF supports both of these bills. As of this writing, no hearings have been scheduled on either of these bills.
Access To Medical Treatment Act
Congressmen Dan Burton (IN-6) and Pete DeFazio have reintroduced the Access To Medical Treatment Act (AMTA) legislation, HR 2792. The bill allows Americans under strict physician supervision and who fit tightly designed protocols to have access to therapies and devices that are undergoing FDA clinical trials as well as access to complementary and alternative medical treatments that may never be in the FDA-approval process because they are not financially viable. The bill contains strict patient protections and does not legalize the use of illegal drugs. The bill would also establish a valuable, complementary private-sector funded biomedical research program, saving taxpayer money while contributing to the federal biomedical research program by identifying promising medical treatments. AMTA would return decision-making to physicians and patients who, in most cases, have no other treatment alternatives. The NHF supports this bill and I am currently working to sign up more supporters.
New Anti-DSHEA Bill
HR 2510, the Dietary Supplement Regulatory Implementation Act, has been introduced. This is another piece of legislation that would increase the authority of the Food and Drug Administration (FDA) to regulate supplements like drugs. Ten years after the DSHEA law was passed, the FDA has not implemented the requirements of existing law, which many at NHF frankly see as a good thing since there are compromise provisions in DSHEA that are less than favorable to the consumer and industry. This bill proposes to authorize more money for the FDA for its DSHEA responsibilities and expanded regulatory power. Granting the FDA more money and authority for a law that it has not been able to carry out in the first place is counter-productive to good governance. Regardless, the bill includes provisions that are anti-supplement in their public-policy purpose. Among other things, it would establish mandatory adverse medical-event reporting requirements. Consumers can already file AER reports with the FDA and we all know that these “reports,” which don’t even have to be genuine, will just be used to trigger the application of drug-like standards to natural products. Instead of trusting basic American intelligence and common sense, the bill would, as usual, put these decisions in the hands of the FDA bureaucrats. Rewarding FDA bureaucrats for non-performance is not responsible government. Dietary-supplement consumers prefer more health freedom of choice and less interference from the FDA, not the reverse. The NHF opposes this bill and is lobbying for its defeat.
Prescription-Drug Reimportation
The Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on SB 334; a drug-reimportation bill sponsored by Senator Byron Dorgan and supported by 30 other Democrat and Republican Senators. The bill would allow U.S. residents to reimport as much as a 90-day supply of prescription drugs from FDA-approved Canadian pharmacies. After 90 days, the legislation would allow licensed pharmacists and prescription-drug wholesalers to reimport drugs from Canada. U.S. residents who travel to Australia, Japan, New Zealand, Switzerland, or current European Union (EU) nations could return with as much as a 90-day supply of prescription drugs for personal use. After one year, pharmacists and wholesalers could freely reimport medications from these countries. Pharmacists and wholesalers that reimport prescription drugs would have to register with the FDA and pay fees of as much as 1% of the price of the medications. These funds would be used to cover the cost of additional federal inspectors and monitoring the chain of custody from manufacturers to consumers. There are several reimportation bills pending in the House and Senate. SB 334 has the most sponsors among the Senate bills. On the House side of Capitol Hill, the reimportation bill that passed last year has been reintroduced and is gaining support. While these are a step in the right direction, a real health-freedom bill would be simple and clear: just let consumers import or re-import the pharmaceuticals that they wish to buy. Period. It is not clear at this time, but it is expected that the big pharmaceutical companies will again strongly oppose any and all reimportation legislation.
DHEA Supplements
On the other side of Capitol Hill, a bill to classify Dehydroepiandrosterone, or DHEA, as an anabolic steroid and add it to the list of controlled substances, SB 1137, has been introduced in the Senate. DHEA dietary supplements have been on the market for over 20 years with the DHEA in these products being derived from a plant in the wild yam family. DHEA is a naturally occurring hormone that has a proven scientific record of having a wide range of health benefits for older Americans and people with chronic conditions. Above all, DHEA-containing supplements are not anabolic steroids. This bill is contrary to the intent of the Anabolic Steroid Control Act (ASCA) enacted last year by Congress. In amending the law, during Senate floor debate, it was made clear that DHEA should not be a controlled substance. Further, the Senate mandated that the Drug Enforcement Agency (DEA) must provide sufficient evidence of illegal abuse among athletes or young people of DHEA supplements before taking action to include it on the list of controlled substances. There has been no evidence presented thus far in this regard; and, to its credit, the DEA is taking the position that DHEA supplements cannot and should not be treated in this manner. In turn, though, this was the reason for the reintroduction of the anti-DHEA bill. The NHF is strongly opposed to this legislation; and, as the NHF lobbyist, I am actively educating Senators and their staff about the disadvantages of this bill.
Stem-Cell Research
Not that anyone should hold their breath, but the House of Representatives recently passed HR 810, a bill to loosen the restrictions on access to stem-cell lines for research purposes. At a recent Senate Appropriations hearing on the NIH budget for next year, Senators specifically raised the issue of whether President Bush’s Executive Order limiting the number of stem-cell lines that could be used for federal biomedical research has hindered research. Senator Arlen Specter (R-PA), the Chairman of the Senate Appropriations subcommittee that funds the National Institutes of Health, asked directors of the individual institutes at the NIH to comment on the logistics of using the federally approved stem cell lines, and whether NIH had given over leadership of the research to California and other States wanting to do the same. Some directors said that the administration's policy – which allows federal funds to be used for research only on stem cell lines that existed before August 2001 – was inadequate. The director of the National Heart, Lung, and Blood Institute said that progress was being delayed. To date, five bills have been introduced. Legislation in the Senate, SB 471, is backed by 21 Democrats and Republicans, including Senators Orrin Hatch (R-UT) and Spector. It seeks to expand the number of stem-cell lines available to federally funded research projects. In the Senate, Majority Leader Bill Frist has thus far refused to entertain any debate or a Senate vote on the issue.
So, all in all, it will be a busy season for us and we will have much to do to keep our health freedoms. But that is nothing new for us, and we shall make our voices heard on all of these health matters so that freedom will prevail.
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