The Good, Bad, and Ugly In the 2003 Congressional Session

By Lee Bechtel
National NHF Advocate

December 5, 2003

First, attribution is given to the really old Clint Eastwood movie – The Good, Bad, and Ugly. In the first session of the 108th Congress, for Americans who passionately care about dietary supplements it was a very eventful year – good and bad. For those who care about the freedom and/or their physician’s access to effective medical treatments approved in other countries but not FDA approved, the year was less eventful. On the other hand, for Americans who were hoping to legally re-import cheaper FDA approved prescription drugs from Canada and twenty-five other countries, it was a really unattractive year in terms of Congressional action and politicians keeping commitments. This is the ugly aspect. On the issues of dietary supplements, the Access to Medical Treatment legislation, and drug re-importation, the 2004 Congressional session holds promise and the potential for using the ephedrine issue as a Trojan horse to repeal provisions in the 1994 DSHEA law. This also falls into the potential ugly category, but moving forward.

Dietary Supplements

S.722, the legislation introduced by Senator Dick Durbin (D-IL) was not offered as an amendment to the FDA spending bill for FY 2004. It can be brought back in 2004, either in the normal legislative process or any other manner the Senator can use. Support for an FDA ban on dietary supplements containing ephedrine ingredients gained momentum on November 6th. In the Senate, Senators Durbin (D-IL) and McCain (R-AZ) introduced Senate Resolution 260, expressing the sense of the Senate that the Food and Drug Administration should remove dietary supplements containing ephedrine alkaloids from the market. On the same day, Representatives Susan Davis (D-CA), James Greenwood (R-PA), Chairman of the Oversight and Investigations Subcommittee, Energy and Commerce Committee, and Congressman Henry Waxman (D-CA) introduced an identical resolution, H.R. 435. Congressional Resolutions are not binding federal law. They are Congressional statements on what public policy should be. These resolutions are intended to support a pending FDA ban on the sale of dietary supplements with ephedrine containing ingredients. During Congressional hearings in July 2003, FDA Commissioner Mark McClellan testified that a ban was “on the table” as an option for the FDA.

As the session came to a close, the assault on dietary supplements continued with the introduction of H.R. 3377. Sponsored by Susan Davis (D-CA), joined by Henry Waxman (D-CA), and John Dingell (D-MI, the Ranking Democrat on the Energy and Commerce Committee), the bill, among other things, would: (1) Narrow DSHEA coverage to only those supplements that consist of vitamin and/or mineral ingredients, unless dietary supplement makers meet additional FDA requirements; (2) Establish the requirement that all manufacturers and processors of the affected dietary supplements (ones not containing only vitamins and/or mineral ingredients) provide to the FDA an update every six months with a list of all of their products, the labeling for each product, a listing of all "major ingredients... including active ingredients,” of these products, and establish the requirement that all manufacturers and distributors, unless specifically waived by FDA, report serious adverse events to FDA within 15 days; and, (3) Give new authority for the FDA to order a manufacturer to conduct post-market surveillance, and require a manufacturer to demonstrate the safety of a supplement if the FDA has "reasonable grounds for believing" that a supplement presents an unreasonable risk of injury or hazard to public health.

This "Son of Durbin” legislation does not create, as does S.722, an FDA pre-approval process for ALL dietary supplements. The exemption granted to supplements containing only vitamin and/or mineral ingredients means that these types of supplements would only be allowed under a newly revised DSHEA law. The House bill has post-market surveillance and adverse event reporting, as does S.722. For supplements identified by the FDA as being a potential public health risk and requiring a safety review, S.722 calls this a "clinical evaluation" whereas H.R. 3377 calls it a "demonstration period". H.R. 3377 does set a limit on how long the FDA can recall and withhold a supplement (six months), whereas S.722 does not set a time limit on removing a product from the market. In short, there are now two active bills that propose to repeal substantive provisions of the DSHEA law and regulations, and would, if enacted, regulate the vast majority of dietary supplements like prescription drugs. There are several other bills that have been introduced, but none of these have the same level of potential impact on consumers' and practioners' access to and future payment for dietary supplements. More detailed information and how you can participate is available at www.thenhf.com.

Access To Medical Treatment – S. 1410 & H.R. 2085

Congressman Dan Burton (R-IN), Chairman of the Subcommittee on Human Rights and Wellness, Government Reform Committee, and a sponsor of H.R. 2085, has sent a letter to Congressman Michael Bilirakis (R-FL), the Chairman of the Health Subcommittee of the Energy and Commerce Committee, requesting a Subcommittee mark-up hearing for this legislation in 2004. While Representative Bilirakis is not a supporter of AMTA, five Republicans - Charlie Norwood (R-Georgia), Joe Barton (R-Texas), Richard Burr (R-North Carolina), Cliff Stearns (R-Florida), and Christopher Cox (R-California), and four Democrats - Ralph Hall (D-Texas), Frank Pallone (D-New Jersey), Anna Eshoo, (D-California), and Gene Green (D-Texas) have previously been sponsors of AMTA legislation. Grassroots action is needed to help build Subcommittee and full Energy and Commerce Committee member support for the Burton request. More detailed information and how you can participate is available at www.thenhf.com.

Drug Re-Importation

The Medicare reform legislation passed Congress, and President Bush will sign it into law. The drug industry is pleased with the final outcome. The final Medicare compromise included the Senate position on re-importation – allowing importation only if the HHS Secretary certifies that the practice is safe, and authorizing a study to assess safety issues. Neither of these is likely to happen in the near future. In short, a continuation of current FDA policy, with a study to delay any real progress, was the final outcome. The outcome is not surprising since the Pharmaceutical Research and Manufacturers of America (PhRMA) spent $8.5 million lobbying Congress in the first half of 2003 working against re-importation legislation.

The final outcome was in stark contrast to what Senators and Representatives were saying leading up to the final vote on the Medicare reform legislation. For example, at the beginning of October, a bipartisan group of Senators introduced a bill designed to pressure Medicare conferees to include substantive changes in re-importation policy in the final Medicare bill. In September, a group of 142 Democrats sent a letter to the House conferees saying that they would vote against a final Medicare bill if it did not include the more extensive House re-importation legislation, which would have allowed re-importation from Canada and twenty-five other countries. A majority of U.S. residents want Congress to legalize the importation of prescription drugs from Canada and Europe and would be willing to pay higher taxes for a Medicare prescription drug benefit, according to a Washington Post/ABC News poll. Of those polled, 69% said that importing prescription drugs from Canada, Europe and other industrialized countries should be legal, while only 29% said that it should not be legal.

To be fair, supporters of the final re-importation provision take the position that the new Medicare law will immediately give senior citizens a discount card to buy their prescription drugs. So, elder Americans will get as much as a 25% discount on their overpriced US version of a drug with their Medicare drug card, as opposed, on average, to a 50% discount compared to the Canadian price of the same FDA approved drug re-imported from Canada. This is good, but what about the rest of Americans not eligible for Medicare.

Looking Ahead On These Issues

When Congress returns for the 2004 legislative session, the good news is that it is an election year. The bad news is that it is an election year. The ugly news is that, to paraphrase Forrest Gump, there is ample Congressional precedent for enactment of federal laws meant to protect stupid people from doing stupid things. To put it into more politically correct language, with regard to dietary supplements, how do you regulate common sense? Regarding dietary supplements, the ephedrine issue is being used as the Trojan horse to repeal the hard fought gain made in 1994 for responsible consumers and medical providers.

The unattractive prospect is that the FDA could release its banning regulation on dietary supplements containing ephedrine ingredients, backed by the immediate passage of the House and Senate Resolutions. But, the public policy atmosphere could get worse with the serious consideration of either S.722 or H.R. 3377. The Waxman/Dingell bill is more dangerous, from a political/legislative viewpoint than is S.722. Why? It proposes to change the original intent of the 1994 DSHEA law. The argument made by supporters of H.R. 3377 would be that supplements containing vitamin and/or mineral ingredients should be covered by DSHEA. Therefore ALL other dietary supplements, now and in the future, should be subject to the prescription drug-like FDA approval, post-market surveillance, and adverse event reporting requirements. Unlike S.722, which is uniform in its application to ALL supplements, H.R. 3377 portends to not regulate “real supplements”, and only to regulate those that were not originally intended to be covered by DSHEA. This line of argument is an easier political and public policy sell than is an outright repeal of DSHEA.

Regarding the AMTA legislation, continued grassroots lobbying is needed to raise Congressional member awareness. The failure of the re-importation issue presents an opportunity. This is related to a “gray” area of the Food, Drug, and Cosmetic Act (FDCA) that does not discriminate between what are “unapproved drugs”. This policy aspect has been researched with many folks. In short, current law and regulations make no differentiation between an approved FDA prescription drug exported to specified twenty-five countries and then re-imported, and a drug or treatment approved in one of these countries but not FDA approved. If brought into the US, both are “unapproved drugs”. The AMTA legislation would, if enacted, allow both types to be freely imported for use, but only under the direct supervision of a licensed medical provider. This provider provision answers the major concern of re-importation – consumer safety. In addition, the AMTA legislation would mandate reporting of positive or negative medical outcomes.

Regarding re-importation, some Democrats who opposed the Medicare bill have begun formulating a strategy to change the legislation's provisions in 2004. Some Senate Democrats will likely seek to add language to the drug reimportation provision to address the direct consumer access issue and the HHS Secretary certification issue.

Please visit the National Health Federation Webpage to keep abreast of federal legislation and how you can help prevent more governmental regulation and preserve individual health care choices.