655 15TH ST, NW, SUITE 700 WASHINGTON, DC 20005 TELEPHONE: 202/452-8444 FAX: 202/429-4519

January 29, 1999

VIA MESSENGER

Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Re: Medication Guide Requirements Final Rule (Docket Number 93N-0371)

Dear Sir or Madam:

        The Food Marketing Institute (FMI) respectfully submits the following comments in response to the Food and Drug Administration's (FDA's) final rule that establishes requirements for the distribution of Medication Guides for selected prescription drugs. 63 Fed. Reg. 66377 (December 1, 1998).

        For your information, FMI is a non-profit association that conducts programs in research, education, industry relations and public affairs on behalf of its 1,500 members and their subsidiaries. Our membership includes food retailers and wholesalers, as well as their customers, in the United States and around the world. FMI's domestic member companies operate approximately 21,000 retail food stores with a combined annual sales volume of $220 billion, which accounts for more than half of all grocery store sales in the United States. FMI's retail membership is composed of large multi-store chains, small regional firms and independent supermarkets. Our international membership includes 200 members from 60 countries.

        In addition, FMI's supermarket members presently operate approximately 6,500 in-store pharmacy departments. Based on current industry trends toward larger store formats and the convenience of "one-stop shopping," we anticipate that the number of supermarket pharmacies will continue to increase in the coming years. In 1998, pharmacies located in a supermarket setting accounted for about $8 billion in outpatient prescription drug sales, which is approximately 12 percent of the retail market for prescription drugs in the United States.

        FMI and its membership strongly endorse the concept that consumers should receive written information regarding their prescription drugs. Providing patients with accurate, meaningful and easily understandable information about their medications is an extremely important goal that supermarket pharmacies not only support but implement routinely. Nonetheless, FMI has serious reservations concerning the lawfulness of FDA's final rule and must oppose its implementation for the reasons stated below.

A.       LEGISLATIVE HISTORY OF SECTION 601 OF P.L. 104-180 CONFIRMS CONGRESSIONAL PROHIBITION AGAINST IMPLEMENTATION OF  ALL ASPECTS OF AUGUST 1995 PROPOSAL, INCLUDING MANDATORY MEDICATION GUIDE PROGRAM

        In August, 1995, FDA issued a proposal intended to increase the information given to patients on the prescription drugs that they are taking. 60 Fed. Reg. 44181 (Aug. 24, 1995) (the "August 1995 proposal"). The August 1995 proposal established goals for the private sector distribution of patient information to specified percentages of the population by certain target dates; if the goals were not reached, the Agency proposed two alternative courses of action. The August 1995 proposal also provided for the implementation of a "mandatory Medication Guide program limited to instances where a product poses a serious and significant public health concern requiring immediate distribution of FDA-approved patient information." 60 Fed. Reg. at 44182.

        While FDA was reviewing comments on the August 1995 proposal, Congress enacted legislation intended to respond to and address the Agency's proposal. In particular, Section 601 of Public Law 104-180 states that the Secretary of Health and Human Services "shall have no authority to implement the proposed rule described in subsection (a)" of Section 601. Pub. Law 104-180, Sect. 601(d) (Aug. 6, 1996). Subsection (a) identifies "the proposed rule of the Food and Drug Administration on 'Prescription Drug Product Labeling: Medication Guide Requirements' (60 Fed. Reg. 44182; relating to the provision of oral and written prescription information to consumers)." Pub. Law 104-180, Sect. 601(a), (Aug. 6, 1996).

        Nonetheless, on December 1, 1998, FDA published a final rule intended to implement the mandatory Medication Guide program described in the August 1995 proposal. 63 Fed. Reg. 66377 (December 1, 1998) (the "final Medication Guide rule"). In the preamble to the final Medication Guide rule, FDA attempts to bifurcate the two programs covered by the August 1995 proposal and further attempts to argue that Section 601 of the Appropriations law prohibits FDA from implementing the voluntary program, but does not prohibit the Agency from adopting the mandatory Medication Guide program. However, the legislative history of Section 601, in which a provision favoring the Agency's interpretation was affirmatively deleted and replaced by a provision that clearly was intended to prohibit FDA from implementing any of the programs proposed in 1995, belies the Agency's attempts to justify the December, 1998 final rule on Medication Guides.

Specifically, H.R. 3603, the precursor bill to Public Law 104-180, originally contained the following provision:

None of the funds appropriated or made available to the Federal Food and Drug        Administration shall be used to implement any rule finalizing the August 25, 1995 proposed rule  entitled "The Prescription Drug Product Labeling; Medication Guide Requirements," except as to  any specific drug or biological product where the FDA determines that without approved  patient information there would be a serious and significant public health risk.

H.R. 3603 at 55 (104^th Cong, 2d Sess.) (emphasis added). As explained in the Committee report on H.R. 3603, this provision "does provide that FDA may implement a final rule now for a very limited number of products, i.e., any specific drug that poses a serious and significant public health risk." H.R. Rept. 104-613 at 102 (104^th Cong., 2d Sess.) (June 7, 1996). The Committee continued by indicating that FDA described the program of interest as one that would "be limited to only a very small number of drugs that cannot be used appropriately without specific written information provided directly to the patient." Id. Clearly, then, the original language in H.R. 3603 was intended to prohibit FDA from implementing the voluntary program described in the August, 1995 proposal, but also to carve out an exemption to permit FDA to establish the mandatory Medication Guide program.

        However, the report on the final language that was enacted indicates that the Committee purposefully deleted the provision quoted above and replaced it with language that did not include permission for the Agency to enact the mandatory Medication Guide program. Indeed, the Report on the bill that was ultimately enacted into law indicates that the final provision "would prohibit the Secretary of Health and Human Services from finalizing FDA's proposed medication guide regulation or developing any type of standard format in the form of a policy statement or guidance document specifying a uniform content for written information provided to consumers about their prescription medications."¹ S. Rept. 104-317 at 132 (104^th Cong., 2d Sess.) (July 11, 1996) (emphasis added). Thus, Section 601 of Public Law 104-180 was specifically written to prohibit FDA from implementing the Medication Guide program.

        Our interpretation of the legislative history is supported by a September 17, 1998 letter sent to the Secretary of Health and Human Services from Senator Thad Cochran, Senator Dan Coats, and Senator Mitch McConnell; both Senators Cochran and McConnell serve on the Subcommittee on Agriculture and Related Agencies Appropriations of the Committee on Appropriations, which authored the final bill. (A copy of this letter is enclosed for your ready reference.) With respect to FDA's interpretation of Section 601 as requiring only part of the August, 1995 proposal to be postponed, the Senators state as follows: "Congress intended that the entire rule, not just the voluntary part, be held in abeyance."

        The legislative history thus makes two points abundantly clear. First, Public Law 104-180 does not distinguish between the two programs proposed by FDA in 1995. That is, the limitation on the Secretary's authority was intended to cover all aspects of the 1995 proposal. Second, as the exemption that was originally provided to authorize FDA to continue with the mandatory Medication Guide program was affirmatively removed from the final legislation and replaced with a more comprehensive prohibition, Congress clearly intended to prohibit FDA from enacting the mandatory Medication Guide program that FDA had the temerity to issue as a final rule on December 1, 1998. Accordingly, we urge FDA to rescind the final Medication Guide rule.

B.         FDA SHOULD EXERCISE ITS EXISTING AUTHORITY TO REQUIRE          PATIENT LABELING ON A DRUG-BY-DRUG BASIS THROUGH THE NEW DRUG APPLICATION APPROVAL PROCESS AND NOTICE  AND COMMENT RULEMAKING

        FMI agrees with FDA that Section 601 of Public Law 104-180 does not preclude the agency from using its existing authority to require written information inserts on a drug-by-drug basis when a determination is made that patients would benefit by receiving FDA approved labeling on a particular medication. Indeed, the legislative history cited by FDA in the preamble to the final Medication Guide rule clearly supports this conclusion.² As a matter of fact, FDA has exercised this authority on numerous occasions over the years and now some 42 prescription drugs must be accompanied by written information inserts when dispensed by a pharmacist to a patient. Thus, FMI urges FDA to use its existing authority on a drug-by-drug basis through the new drug application (NDA) review process and notice and comment rulemaking for those prescription drugs that the agency determines pose a serious and significant health concern.

        C.     FDA RULE IS AN ATTEMPT TO REGULATE PHARMACY PRACTICE

        While FDA does indeed have legal authority over the content of pharmaceutical manufacturers' labeling as well as prescription drug advertising, FDA has no authority to regulate the professional practice of pharmacy, which is clearly the purview of the state Boards of Pharmacy. FMI, therefore, opposes this final rule on the grounds that it is an infringement on the professional practice of pharmacy and encroaches on the core responsibilities of the state Boards of Pharmacy with respect to patient care, education, oral counseling and the dissemination of written information to patients.

D.  LIMITING APPLICATION OF FINAL MEDICATION GUIDE RULE PRIMARILY TO DRUGS USED ON AN OUTPATIENT BASIS WILL PREVENTACHIEVEMENT OF OSTENSIBLE GOAL OF MEDICATION GUIDE PROGRAM

        The ostensible purpose of FDA's Medication Guide program is to provide patients with increased access to information in order to educate patients regarding the effects of the drugs and to further patients' ability to discuss the associated issues with their health care providers. Indeed, the Agency has determined that access to this information is so important that FDA removed the exemption previously proposed for drugs administered in emergency situations. 63 Fed. Reg. at 66382.

        At the same time, however, FDA has decided to limit the application of the rule to drugs primarily used on an outpatient basis. Thus, the Agency is defeating the purported goal of the rule for a significant portion of the population, e.g., patients in institutional settings such as hospitals or nursing homes, who are no less entitled to be educated regarding their medication than the rest of the population.³ Moreover, as the Medication Guide program will impose few, if any obligations on physicians or other health care providers, community pharmacists are asked to shoulder a disproportionate portion of the responsibility under the terms of the final rule. If FDA determines that it is in the best interest of persons who are taking a particular drug to receive a Medication Guide, all persons who are taking the drug, regardless of whether the medication is dispensed by a pharmacist or administered by a health care provider, should receive access to that information.

        E.     FDA'S RULE WILL CREATE CONFUSION AMONG PATIENTS

        FMI is concerned that the FDA final rule will increase confusion among patients because the Agency's rule creates a new class of patient labeling that will differ distinctly from existing written information that patients now receive with their medications, such as patient package inserts, as well as the patient information provided by the private sector as a result of the on-going voluntary collaborative plan between the Agency and industry.

        F.     FDA RULE SHOULD REQUIRE INCLUSION OF MEDICATION GUIDE IN                    UNIT-OF-USE PACKAGING

        Under the original August 1995 proposal, FDA would have required the manufacturer or distributor of a drug product that was intended to be dispensed in a unit-of-use container to provide a Medication Guide with each package intended for distribution to patients. Proposed Section 208.24(c), 60 Fed. Reg. at 44237. The Agency received comments objecting to this requirement; the comments asked FDA to allow manufacturers the option of providing sufficient paper copies or providing the dispenser with the means of supplying Medication Guides.

        Despite FDA's recognition that a "unit-of-use package with enclosed patient information guarantees that patients receive the information" and that "no alternative system does so," the Agency amended the final Medication Guide rule to remove this requirement. 63 Fed. Reg. at 66391. FDA states that the amendment "was not an easy decision," but offers no justification for the change to the rule. Id. If the Agency is truly committed to the Medication Guide program, FDA should reconsider its decision and require that Medication Guides be distributed in unit-of-use packaging.

        G.     CONCLUSION

        For the reasons stated above, FMI urges FDA to comply with the Congressional mandate set forth in Public Law 104-180 and to rescind the final rule on mandatory Medication Guides. Rather than promulgating additional regulations, FDA should use its existing authority to require patient information through notice and comment rulemaking on a drug-by-drug basis. Moreover, we recommend continued collaboration between FDA, the pharmaceutical industry, and health care professionals, especially pharmacists, to develop and improve written information that will assist patients in using their medications more effectively.

        We appreciate the opportunity to provide you with our comments and your considered attention to our concerns.

Sincerely,

Tim Hammonds

President and CEO

¹    The report indicates that the language in the final bill was modeled after a provision in Senate bill 1477. S. 1477 (104^th Cong., 2d Sess.). The report on this bill adds little to the legislative history discussed above. See S. Rept. 104-284 (104^th Cong., 2d Sess.) (June 20, 1996).

²    Section 601 "[i]s not to be construed as prohibiting the FDA from using its existing authority or regulatory authority to require as part of the manufacturers' approved product labeling the dispensing of written information inserts to consumers on a case-by-case basis with select prescription drugs to meet certain patient safety requirements." 63 Fed. Reg. at 66378, citing S. Rept. 104-317 at 132 (emphasis added).

³    FDA states that "distributing Medication Guides to institutionalized patients is unnecessary because medications dispensed in such facilities are usually administered directly by health care professionals who are readily available to answer patients' questions about their medications." 63 Fed. Reg. at 66392. With all due respect, we disagree with the Agency's assertion regarding the ready availability of health care providers in all institutional settings. As with patients using drugs on an out-patient basis, institutionalized patients, or their designees, should be afforded the opportunity to learn about their medications so that they might better be able to discuss the medications with their health care providers.

Enclosure