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News Analysis
DESI Drugs Killed from Medicaid; Fate Unclear The decision by Congress in August to halt Medicaid payments for some 119 prescription drugs that have not yet been proven effective under the Food and Drug Administration' s DESI review will affect pharmacy practice for some time to come. The status of many of the drugs on the list may not be clarified. for several years. In August, Congress passed a tax bill containing a provision that will forbid Medicaid from paying for 119 prescription drugs that have been used for many years but have never been proven effective . They are part of FDA's DESI (Drug Efficacy Study Implementation) program which, as a result of the 1962 amendments to the Food, Drug and Cosmetic Act, was formed to study the effectiveness of all prescription drugs introduced in 193~62.
IA Reprieve Ended Medicaid reimbursement of many DESI drugs that had not yet been proven effective was scheduled to have stopped last fall. But through the efforts of the American Pharmaceutical Association, other professional organizations, and industry, pharmacists were granted a reprieve until September 1982. The latest measure, buried in the new tax bill passed this summer, has ended that reprieve. On September 30, Medicaid payments on these drugs stopped . Assuming that Congress does not backtrack, the ball is in FDA's court. Just when these drugs will be cleared as "effective" or removed from the market due to ineffectiveness depends on how quickly FDA moves in finishing the DESI rev1ew. The agency is under a court order by Judge William B. Bryant of the U.S . District Court of the District of Columbia to complete the review by June 1984. But hearings requested by manufacturers in response to FDA attempts to remove products from the market could go on for several years beyond that. In an interview with American Pharmacy, pharmacist Jerome A.
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Halperin, acting director of FDA's Office of Drugs, said that the DESI review is " moving along very well. " Since the agency was ordered to complete the review by 1984, the program has been monitored closely and timetables have been established for each of the more than 200 products remaining to be resolved in the review . FDA staff is confident that the review itself will be completed by the court-ordered deadline . What will not be completed by 1984 will be hearings for products for which there is still some doubt of effectiveness . When the data on a drug product's effectiveness is less than convincing to FDA, the agency can ask the manufacturer for further data. If those data are solid, the drug is approved. If not, the agency can then publish in the Federal Register a notice of intent to remove the product from the market. At that point, the manufacturer has the opportunity to request a hearing before an administrative law judge . If a hearing is requested, FDA can either issue a summary de-
N®~~ &IIDfflfi)r~ll~ nial of the request (if the agency is convinced that the product is definitely not effective) or it can grant the manufacturer a hearing (if it's a close call) . Currently, there are about 160 products for which hearing requests are pending. In addition, hearing requests for more than 150 similar or related products are pending. The decisions made in the DESI review affect not only the more than 3,000 products approved from 193~62 that were part of the original DESI program, but also thousands of similar and related products. Since DESI started in the mid1960s, almost 10,000 products have been removed from the market. The DESI review has made final decisions on 92.8% of the drugs in
its charge . Of these, 69 % have been found effective, and 31 % ineffective and removed from the market.
Exempt Drugs Most of the products that Congress has removed from the Medic· aid program are in the hearing-request stage or have what FDA calls "paragraph 14" status. This refers to a section of Judge Bryant's decision which concerns drug groups containing more than 200 products that are exempt from the 1984 deadline. These "medically necessary" drugs, including the coronary vasodilators and parenteral multivitamins, have confounded researchers because, for many of the drugs, testing for effectiveness is extremely difficult. Take, for example, the parenteral multivitamins: How does one accu· rately measure their effect? What baseline is used? What effects are to be measured? What methodology can be used? What size should the dosages be? According to DESI review chief Dr. Paul A. Bryan, protocols for studying these agents have finally been developed and studies are at last underway . Anabolic steroids, used for arthri· tis therapy, have also caused problems for reviewers. It takes more than 10 years for the effects of these drugs to show up . However, some long-term studies are nearing completion and answers may be in soon. Despite the problems in studying these drugs, FDA does expect to complete the review by 1984. Although the DESI review is moving ahead and the status of some drugs will undoubtedly be resolved within the next two years, others will remain in limbo for several years thereafter. What effect this will have on medical and pharmacy services for the poor is unclear. What is clear, however, is that the effectiveness questions that have plagued certain prescription drugs (as well as the nonprescription drugs in FDA's OTC review) for more than a decade will not disappear -PAM overnight.
American Pharmacy Vol. NS22, No. 10, October 198215211 Arnerican Pharr
IA Reprieve Ended Medicaid reimbursement of many DESI drugs that had not yet been proven effective was scheduled to have stopped last fall. But through the efforts of the American Pharmaceutical Association, other professional organizations, and industry, pharmacists were granted a reprieve until September 1982. The latest measure, buried in the new tax bill passed this summer, has ended that reprieve. On September 30, Medicaid payments on these drugs stopped . Assuming that Congress does not backtrack, the ball is in FDA's court. Just when these drugs will be cleared as "effective" or removed from the market due to ineffectiveness depends on how quickly FDA moves in finishing the DESI rev1ew. The agency is under a court order by Judge William B. Bryant of the U.S . District Court of the District of Columbia to complete the review by June 1984. But hearings requested by manufacturers in response to FDA attempts to remove products from the market could go on for several years beyond that. In an interview with American Pharmacy, pharmacist Jerome A.
8
Halperin, acting director of FDA's Office of Drugs, said that the DESI review is " moving along very well. " Since the agency was ordered to complete the review by 1984, the program has been monitored closely and timetables have been established for each of the more than 200 products remaining to be resolved in the review . FDA staff is confident that the review itself will be completed by the court-ordered deadline . What will not be completed by 1984 will be hearings for products for which there is still some doubt of effectiveness . When the data on a drug product's effectiveness is less than convincing to FDA, the agency can ask the manufacturer for further data. If those data are solid, the drug is approved. If not, the agency can then publish in the Federal Register a notice of intent to remove the product from the market. At that point, the manufacturer has the opportunity to request a hearing before an administrative law judge . If a hearing is requested, FDA can either issue a summary de-
N®~~ &IIDfflfi)r~ll~ nial of the request (if the agency is convinced that the product is definitely not effective) or it can grant the manufacturer a hearing (if it's a close call) . Currently, there are about 160 products for which hearing requests are pending. In addition, hearing requests for more than 150 similar or related products are pending. The decisions made in the DESI review affect not only the more than 3,000 products approved from 193~62 that were part of the original DESI program, but also thousands of similar and related products. Since DESI started in the mid1960s, almost 10,000 products have been removed from the market. The DESI review has made final decisions on 92.8% of the drugs in
its charge . Of these, 69 % have been found effective, and 31 % ineffective and removed from the market.
Exempt Drugs Most of the products that Congress has removed from the Medic· aid program are in the hearing-request stage or have what FDA calls "paragraph 14" status. This refers to a section of Judge Bryant's decision which concerns drug groups containing more than 200 products that are exempt from the 1984 deadline. These "medically necessary" drugs, including the coronary vasodilators and parenteral multivitamins, have confounded researchers because, for many of the drugs, testing for effectiveness is extremely difficult. Take, for example, the parenteral multivitamins: How does one accu· rately measure their effect? What baseline is used? What effects are to be measured? What methodology can be used? What size should the dosages be? According to DESI review chief Dr. Paul A. Bryan, protocols for studying these agents have finally been developed and studies are at last underway . Anabolic steroids, used for arthri· tis therapy, have also caused problems for reviewers. It takes more than 10 years for the effects of these drugs to show up . However, some long-term studies are nearing completion and answers may be in soon. Despite the problems in studying these drugs, FDA does expect to complete the review by 1984. Although the DESI review is moving ahead and the status of some drugs will undoubtedly be resolved within the next two years, others will remain in limbo for several years thereafter. What effect this will have on medical and pharmacy services for the poor is unclear. What is clear, however, is that the effectiveness questions that have plagued certain prescription drugs (as well as the nonprescription drugs in FDA's OTC review) for more than a decade will not disappear -PAM overnight.
American Pharmacy Vol. NS22, No. 10, October 198215211 Arnerican Pharr