Legislature(2003 - 2004)
03/03/2003 03:16 PM House L&C
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* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
HB 51-LABELING OF PRESCRIBED DRUGS Number 0040 CHAIR ANDERSON announced that the first order of business was HOUSE BILL NO. 51, "An Act requiring pharmacists to include generic drug information on containers in which brand-name prescription drug orders are dispensed." [The bill before the committee was CSHB 51(HES), Version 23-LS0191\I.] Number 0060 REPRESENTATIVE PAUL SEATON, Alaska State Legislature, sponsor of HB 51, testified that the bill requires that prescription labels for brand-name drugs must also include the generic name. He said the bill addresses a common occurrence in which a person gets a prescription filled at one drug store and then obtains a refill from a different pharmacy; the result is two prescriptions with no indication that they contain the same medicine. The labeling required by HB 51 enables consumers to see that they have several containers of the same drug. When the bill was first drafted, Representative Seaton said he considered requiring the listing all the brand-names on the label, but decided against it. Such a label would unfairly list the products of the drug company's competitors. Number 0328 REPRESENTATIVE SEATON described HB 51 as a consumer protection bill. He said that many senior citizen centers reported instances among their seniors of overdosing because of multiple bottles of the same medicine. He pointed to the bill packet, which contains a letter from the administrator of Homer Senior Citizens, Inc., as well as other letters of support. A [January 17, 2003] memorandum from Legislative Research quotes a report that states that 15 percent of medication errors are due to confusion between drug names. The same memo quotes the FDA [U.S. Food and Drug Administration] as listing 15 suggestions for eliminating drug overdoses; one recommendation is to provide brand and generic names on all medication labels. REPRESENTATIVE SEATON said HB 51 was amended during a hearing in the House Health, Education and Social Services (HES) Standing Committee. The HES committee substitute (CS) [before the committee now] has one change from the original bill. Instead of requiring that the generic name be written below the brand- name in parentheses, the CS allows it to be placed anywhere near the brand-name. Some pharmacies already write the generic name below or above the brand-name, so the CS eliminates the need for pharmacists to change their computer programs. He said the bill information packet also contains prescription samples demonstrating the single-name label as well as the label with both brand and generic names. Number 0430 CHAIR ANDERSON expressed his appreciation for the resource materials in the bill packet. He also noted that the following committee members are cosponsors of HB 51: Representatives Anderson, Crawford, Dahlstrom, Gatto, and Lynn. He asked if anyone in the audience or on teleconference wished to testify. With no additional testimony, he invited questions from committee members. Number 0439 REPRESENTATIVE GATTO explained that he is a cosponsor of HB 51 but had questions about the definition of generic drugs. He asked whether the prescription label must show the generic name and list all the various brands of the same drug. REPRESENTATIVE SEATON said HB 51 requires that the generic name be included on a brand-name prescription. But it does not require the listing of all other brand-names for that medicine. Number 0502 REPRESENTATIVE GATTO explained that he wants to understand the definition of generic before the bill leaves the committee. He used the example of Benadryl, which contains diphenhydramine. He asked whether diphenhydramine is the generic or the scientific name. REPRESENTATIVE SEATON said he was told by legislative legal staff that generic is defined in numerous places in state law. Number 0596 REPRESENTATIVE ROKEBERG asked whether there's only one generic name for each drug. He asked whether the FDA, when it approves a drug for use, stipulates one specific generic name. REPRESENTATIVE SEATON replied yes, the generic name is the name of the drug. He added that once the original patent runs out, there may be many brand-names. REPRESENTATIVE ROKEBERG questioned whether drug companies can extend their patents by making small changes in the original formulas. He asked if the generic name would change if the drug's formula changed. Number 0670 REPRESENTATIVE SEATON replied that regardless of the color, shape, or other characteristics of the medication, as long as the drug is the same, it carries the same name. If the drug gets a new patent, then a generic version cannot be manufactured or marketed until the new patent expires. REPRESENTATIVE ROKEBERG said his concern is that drug companies will modify their drugs to extend their patents, delaying generic sales by their competitors. He asked if the sponsor has researched this aspect of drug sales and labeling. Number 0760 REPRESENTATIVE SEATON said he had not researched this point. But, he added, if the drug is still patented, there can be no generic version, and a patented drug cannot be filled in two different ways. REPRESENTATIVE ROKEBERG asked Representative Seaton if he had talked to any drug companies, the PhRMA (Pharmaceutical Research and Manufacturers of America) lobby, or the Board of Pharmacy about HB 51. REPRESENTATIVE SEATON said he had contacted PhRMA and Medco Health Solutions, a large HMO [health maintenance organization], both of which had no objections to HB 51, and Aetna, which supported the bill. Number 0880 CHRIS KNIGHT, Staff to Representative Paul Seaton, Alaska State Legislature, replied to a question from Representative Rokeberg about the Board of Pharmacy. He explained that the sponsor spoke with the board to determine whether this prescription labeling could be accomplished by a bill or through regulation. The board indicated it planned to discuss this question at its next meeting. The sponsor went ahead with the bill. Mr. Knight reported that the board supported the concept and did not object to the bill. REPRESENTATIVE ROKEBERG asked whether there's enough room on a prescription label to include the generic name. Number 0932 REPRESENTATIVE SEATON explained that he considered the issue of limited space when he decided against an early draft of the bill that required listing generic and all other brand-names for any given drug. He said HB 51 adds one line of text or one name close to the brand-name. Family Pharmacy in Eagle River supplied the sample labels in the members' bill packets, demonstrating where its computer software places the generic name. He said Family Pharmacy did not have a problem with HB 51. Number 0966 REPRESENTATIVE LYNN said that he was proud to be a cosponsor of HB 51. He compared the naming of drugs with the naming system for flowers and plants: each has a scientific Latin name but a variety of common names. He explained that in brand-name over- the-counter drugs, the label shows the active ingredient, usually the generic name. He said this bill is needed and is a step in the right direction. REPRESENTATIVE SEATON confirmed a comment by Representative Lynn that under HB 51, a prescription label for a generic drug would include only the generic name; a prescription label for a brand- name drug would include both the brand and generic names. In the case of two brand-name prescriptions, each label would have the generic name so they could be cross-referenced. Currently, the generic name is usually listed on the data sheet that accompanies the prescription. Number 1070 MR. KNIGHT, in response to a question from Representative Rokeberg, explained that when the FDA approves patents, it assigns a generic name to every patented drug. He used the example of Viagra, assigned a generic name [sildenafil] by the FDA when it was patented; that patent is close to expiration. REPRESENTATIVE ROKEBERG asked about the situation in which a generic name is listed next to the brand-name on a prescription label, but the generic version is not on the market. He asked if this raises the expectation that the cheaper version is available. Number 1170 REPRESENTATIVE SEATON responded that the generic name on the prescription is the name of the medication, even if it's not available to purchase in a generic version. House Bill 51 requires the pharmacist to label drugs so that people can identify duplicate bottles of the same medicine and avoid overdoses. MR. KNIGHT explained that Family Pharmacy in Eagle River already puts the generic and brand-names on the prescription label because it can and because it thinks it's a good idea. He responded to a question by Representative Rokeberg about whether consumers would be prompted to request a generic drug that is not yet available in a cheaper form. Mr. Knight related a conversation with a pharmacist who said he would be pleased if more people inquired about generic drugs and took an interest in their medications. Number 1312 REPRESENTATIVE GATTO mentioned the example of Bayer aspirin and asked which name is generic and which is the brand-name. REPRESENTATIVE SEATON replied that acetylsalicylic acid is the generic name, but HB 51 does not cover over-the-counter drugs. The bill covers the labeling of powerful prescribed medications so consumers can tell what drugs they are supposed to be taking. He said research shows that 59 percent of drugs are misused, and 15 percent of all medication errors are due to labeling problems. Number 1374 REPRESENTATIVE GATTO explained that he was trying to get questions on the record that might be asked later in the legislative process. He again asked, in the case of Bayer aspirin and acetylsalicylic acid, which is the brand-name, the generic name, and the scientific name. CHAIR ANDERSON commented that asking about aspirin is like comparing apples to oranges because aspirin is not a prescription drug; it would never to subject to this labeling law. REPRESENTATIVE GATTO used the example of LAMISIL, terbinafine, a fungicide, and asked which is the brand-name. REPRESENTATIVE SEATON stated that a fungicide is a type of medicine, LAMISIL is a brand-name, and terbinafine is the generic name. There could be lots of different brand-names, but each ointment would need to have "terbinafine" on the label. REPRESENTATIVE GATTO said he supports HB 51 but wanted some clarity through discussion. REPRESENTATIVE LYNN mentioned how his pharmacist will routinely offer him the choice of a brand-name or generic version of a prescribed medication. Number 1578 REPRESENTATIVE SEATON, in response to a question from Representative Guttenberg, said he was not sure whether pharmacists in Alaska are required to advise customers if the cheaper generic alternative is available. The point of HB 51 is to prevent overdoses from two prescriptions for the same medication. He reiterated that drug manufacturers did not object to the labeling in this bill. REPRESENTATIVE ROKEBERG said he agreed with Representative Gatto's desire to get on the record the difference between generic, scientific, and brand-names. Number 1688 REPRESENTATIVE LYNN moved to report CSHB 51(HES) out of committee with individual recommendations and the accompanying zero fiscal note. There being no objection, CSHB 51(HES) was reported from the House Labor and Commerce Standing Committee.
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