HJR 31 - FEDERAL FOOD, DRUG, AND COSMETIC ACT Number 030 CHAIRMAN ROKEBERG announced the first order of business would be HJR 31, "Requesting the United States Congress to amend the Federal Food, Drug, and Cosmetic Act," sponsored by Representative Pete Kott Number 086 NICOLE POIRRIER, Intern to Representative Pete Kott, Alaska State Legislature, came before the committee to address HJR 31. She said the resolution asks Congress to take a look at the Federal Food, Drug and Cosmetic Act. Currently, there are several products that are in the testing phase that could be more rapidly approved to assist patients suffering from various illnesses. She said HJR 31 asks Congress to speed up that process. Number 149 REPRESENTATIVE TOM BRICE asked Ms. Poirrier if she has specific recommendations of the Food and Drug Administration (FDA) about how they could speed up that process. REPRESENTATIVE PETE KOTT, sponsor of HJR 31, responded, "In specific, there are no general areas that we're specifically looking at. In generalities, that whole U.S. code is a fairly extensive session. We actually ran off a copy, but not to bore you with the details, we tried to peruse it as much as possible and tried to glean from what steps are involved and it's a nightmarish code that's really difficult to understand to begin with." Representative Kott said it is his understanding that Congress currently has two measures, one in the House and one in the Senate, that analyzes the code for those red tape areas that could expedite products coming to market much more sooner than they currently are. He pointed out many of the products are in the testing stage and could take three to eight years to be released. He said an example is AZT, which treats AIDS (acquired immune deficiency syndrome), was in the experimental stage for about four and a half to five years. He said he thinks that those people who suffered from the virus would have liked to have taken their chances early on versus not having anything for treatment. Representative Kott said the resolution asks Congress to look at that area in the code and determine what areas need to be changed that could potentially expedite these products coming to market. Number 307 REPRESENTATIVE JOE RYAN said Representative Kott talked about dissemination of information. He asked him if he knows if Congress has any plans in "ringing" in these people a little bit. He said he has noticed that lately they prohibit anybody from saying (indisc.) to say what benefits may be derived from using a certain vitamin and yet, physicians will give you certain vitamins during pregnancy to make sure certain diseases don't happen because it could be from a vitamin deficiency that causes these diseases. Yet the FDA won't allow anybody to put on a vitamin label any information as to what the use of vitamins will do to help you. They shut down people's ability to make statements that are proven scientific facts. REPRESENTATIVE KOTT said he isn't aware of any of the specifics that Representative Ryan is addressing. He pointed out many of the products that are currently being dispensed are dispensed for a certain ailment that a product has been approved to be dispensed for. He said, "What I am of the understanding is that we're also asking, through the Congressional legislation, is for those products that are currently approved to at least provide additional, and this is the pharmaceuticals, provide information to those physicians for some of the ailments that the product is not approved for that could lead to them at least assisting in the discussion and dialogue with patients perhaps offering additional options." He said the whole process is basically one that's a very difficult one and there is a lot of red tape and hurdles to jump through. He noted he thinks we have come a long ways from the initial writing of the code and it's time to revisit it. He said maybe there needs to be a preapproval stage for those cases that are terminal. Number 528 CHAIRMAN ROKEBERG said he noticed in his committee file that there is a page of information referencing the activities of the 104th Congress and specific references to SB 1477 and HR 3199. He asked if those are Senate joint and the House resolutions regarding this activity. REPRESENTATIVE KOTT said that is correct. CHAIRMAN ROKEBERG asked where those currently are in the realm of things. REPRESENTATIVE KOTT said they're moving through the process at a relatively stable and slow rate as most Congressional actions move. He said HJR 31 asks Congress to continue moving that legislation through the process. He said he is not asking that public safety be jeopardized in any shape of fashion. It asks them to look at the procedures involved to see if we can maintain public safety as well as to move those products to market. CHAIRMAN ROKEBERG said HJR 31 is intended to spur along the passage of those particular Congressional actions. REPRESENTATIVE KOTT said that is correct. CHAIRMAN ROKEBERG asked if the Pharmaceutical Association is interested in this activity. REPRESENTATIVE KOTT indicated they are supportive. Number 632 REPRESENTATIVE BILL HUDSON asked if this is something that is moving through the National Conference of State Legislatures (NCSL) where there is a broad base of states that are appealing for this kind of legislation. REPRESENTATIVE KOTT said he isn't sure if it is supported by the NCSL, but said he wouldn't be surprised if it is because they are generally in support of this kind of legislation. He noted there are 20 plus states that have submitted resolutions of similar nature. Number 711 REPRESENTATIVE JOHN COWDERY made a motion to move HJR 31 out of committee with individual recommendations. CHAIRMAN ROKEBERG asked if there was an objection. Hearing none, HJR 31 moved out of the House Labor and Commerce Standing Committee.