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Legislation & Regulation
Legislation & Regulation
Most Generic Drugs Are Safe, But Approval Process Remains in 'Disrepair' nly 1.1% of the 2,556 generic O drugs tested by the Food and Drug Adminstration (FDA) did not meet quality specifications such as potency, purity, and dissolution, testified Commissioner Frank E. Young at a congressional hearing on generic drugs.
Former FDA Commissioner Young
That rate, said Young, is consistent with the deficiency rates normally found for both brand name and generic drug products. "So for now," said Young, "if consumers are taking generic drugs, they should continue with them. If they have questions or concerns about their generic prescriptions, they should consult their physicians or pharmacists." Young spoke at the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce hearing on generic drugs November 17 -just four days after he resigned as head of the nation's chief drug-regulating office (see story). Young was asked to report on the FDA's ongoing investigations of the generic drug approval process and the results of the agency's tests on the 30 best-selling generic drugs. Investigations began last spring after several problems were uncovered in the generic drug approval 14
process, ranging from bribery of FDA officials to falsification of bioequivalency data by generic drug manufacturing firms. According to Young, the FDA's investigations of the generic drug industry included the following: • Labor a tory Review of the Top 30 Generic Drugs. The FDA performed more than 36,000 tests on 2,556 drugs at 17 FDA laboratories across the country. Only 27 drugs (1.1 %) were found not to conform to product quality specifications set forth by the United States Pharmacopeia or the FDA. Although no products were found to be unsafe, laboratory findings led to the recall of 12 different strengths of four drug products. • Analysis of Bioequivalence Test Samples. The FDA is conducting labor-intensive analytical reviews to check for fraud on more than 1,000 product samples. The final results of these tests are yet to be released; however, of the approximately 500 samples analyzed to date, the FDA has uncovered one case of fraud. • Inspections of Suspect Firms. This effort involves plant inspections of 11 companies suspected of possible corruption or manufacturing problems. The FDA found that four firms had misrepresented information to the FDA on their abbreviated new drug applications (ANDA), and eight firms had deviated from approved manufacturing procedures. To date, these investigations have led to 54 drug recalls, three ANDA withdrawal actions covering 29 products, one voluntary product recall, and several referrals for criminal prosecution to the Department of Justice. • A Cross-sectional Inspection of the Industry. An additional 20 firms were inspected on the basis of ANDAs held by each company and the availability of samples to verify that bioequivalency tests were performed honestly. The FDA discovered one case of fraud and two cases of manufacturing violations.
Summarizing his report to the committee, Young said, "In general we are cautiously reassured, since we have seen no evidence to date indicating that generic medications now in use pose a serious safety threat." @
Dingell Cites Problems While the agency's finding that most generic drugs are safe and effective may ease the minds of pharmacists and patients, Subcommittee Chairman John D. Dingell (D-Mich.) reported that more work needs to be done to ensure the quality of prescription drugs. Dingell cited three problems: • The generic drug approval process still needs fine-tuning. Scarce resources, low morale, and bureaucracy have kept the generic drug process in "disrepair," and "unless the system and personnel are completely reformed, the arbitrariness that led to corruption will remain," he said. • The Department of Health and Human Services has not taken decisive action against all the companies that were found guilty of providing falsified data or other wrongdoing. Companies have been allowed to continue selling products even though questions remain about their credibility. • Congress has not yet received a legislative proposal to address the .fraud and corruption in the generic drug approval process. ''We have repeatedly heard inadequacies in the statutory framework used as an excuse, but no initiatives have been forthcoming," Dingell said... '~t some point, talk must give way to action." The committee is expected to release a report with legislative recommendations early in1990.
American Pharmacy, Vol. NS30, No. 1 January 1990/14
Legislation & Regulation
Halcion Found Safe by FDA; New Labeling Requested he most widely prescribed sleeping agent in the world, Upjohn T Co.'s Halcion, was found safe for most patients by an advisory committee of the Food and Drug Administration (FDA) in September. The committee urged stronger labeling to explain more clearly what side effects some patients might expect. The FDA investigated Halcion after receiving reports of seizures, amnesia, hallucinations, personality disorders, and other side effects. Some reports linked Halcion, a benzodiazepine hypnotic, to violent behavior. In a lawsuit against Upjohn, a 58year-old Utah woman charged that Halcion made her shoot her mother and made her lose all memory of the act. Two physicians testified that Halcion contributed to the woman's violent behavior, and a judge dismissed murder charges against her. Upjohn contends that the woman was taking other drugs
at the time and that Halcion wasn't to blame. There have been attempts to link Halcion to another murder and another attempted murder. Paul Leber, director of the FDA's Neuropharmacological Drug Products Division, said there was little or no evidence linking Halcion to the murders or to other violence. "Much of the alarm caused by reports of these incidents is not borne out by what the committee has seen," he said. "There is no emergency, and we don't see a public health hazard. The vast majority of people who use these drugs don't have anything go wrong." The committee recommended that physicians receive a stronger, more detailed warning stating that Halcion might be associated with an increased risk of amnesia. A package insert or other literature for patients should be developed saying that Halcion and other benzodiaze-
pine hypnotic sleeping pills are associated with "traveling amnesia," a condition much like jet lag in which the effect of a sleeping pill taken before ~ir travel lasts longer than expected, virtually incapacitating the traveler after the trip. The literature for patients about this reaction would also apply to the other two drugs in Halcion's class: Restoril, made by the Sandoz Pharmaceuticals Corp., and Dalmane, made by Hoffmann-La Roche, Inc. Leber said it would probably take at least six months for the FDA and the industry to work up drafts of the revised labeling and patient information for the committee to review. The committee is also considering whether to allow Upjohn to expand the market for the antianxiety drug Xanax, its leading revenue producer, to permit its use to treat panic disorders. ®
Young Assumes Nevv Post at HHS
F
rank E. Young, who resigned as Commissioner of the Food and Drug Administration (FDA) November 13, is assuming the newly created position of deputy assistant secretary for health/science and environment at the Department of Health and Human Services (HHS). HHS has named James Benson, an 18-year veteran of the agency, as interim FDA commissioner. In his new job, Young will be responsible for identifying and analyzing technological developments that impact the nation's health care system. He will also help coordinate the development and use oftechnology, nutrition, and food safety within the Public Health Service. Rumors of Young's impending departure had been circulating since the first generic drug scandals hit the FDA last summer. The agency began its search for a replacement several weeks before Young an-
nounced his resignation. Most federal officials believe that Young, who had held the position since 1984, was forced out by the Bush administration, which was displeased over the generic drug scandals that led to questions over the safety of generic drug products. But John D. Dingell (D-Mich.), head of the congressional committee investigating the generic drug scandals, believes that Young did an admirable job and instead blames the policies of the Reagan administration. "Frank Young's intentions were good, and he did his best when problems were brought to light. But he was handicapped by both the budgets and attitudes of an administration that let the agency go to seed," Dingell said. Young, who was the keynote speaker at the APhA/Academy of Pharmaceutical Research and Sci-
American Pharmacy, Vol. NS30, No.1 January 1990115
ence End-of-Summer Science Symposium in both 1989 and 1988, is credited with speeding the process of testing and approving potentially lifesaving drugs under investigation, specifically drugs for AIDS. ®
PRESERVATION
PLAN ON IT Write:
National Trust for Historic Preservation Department PA 1785 Massa,c husetts Ave., N.W Washington, D.C. 20036
15
Most Generic Drugs Are Safe, But Approval Process Remains in 'Disrepair' nly 1.1% of the 2,556 generic O drugs tested by the Food and Drug Adminstration (FDA) did not meet quality specifications such as potency, purity, and dissolution, testified Commissioner Frank E. Young at a congressional hearing on generic drugs.
Former FDA Commissioner Young
That rate, said Young, is consistent with the deficiency rates normally found for both brand name and generic drug products. "So for now," said Young, "if consumers are taking generic drugs, they should continue with them. If they have questions or concerns about their generic prescriptions, they should consult their physicians or pharmacists." Young spoke at the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce hearing on generic drugs November 17 -just four days after he resigned as head of the nation's chief drug-regulating office (see story). Young was asked to report on the FDA's ongoing investigations of the generic drug approval process and the results of the agency's tests on the 30 best-selling generic drugs. Investigations began last spring after several problems were uncovered in the generic drug approval 14
process, ranging from bribery of FDA officials to falsification of bioequivalency data by generic drug manufacturing firms. According to Young, the FDA's investigations of the generic drug industry included the following: • Labor a tory Review of the Top 30 Generic Drugs. The FDA performed more than 36,000 tests on 2,556 drugs at 17 FDA laboratories across the country. Only 27 drugs (1.1 %) were found not to conform to product quality specifications set forth by the United States Pharmacopeia or the FDA. Although no products were found to be unsafe, laboratory findings led to the recall of 12 different strengths of four drug products. • Analysis of Bioequivalence Test Samples. The FDA is conducting labor-intensive analytical reviews to check for fraud on more than 1,000 product samples. The final results of these tests are yet to be released; however, of the approximately 500 samples analyzed to date, the FDA has uncovered one case of fraud. • Inspections of Suspect Firms. This effort involves plant inspections of 11 companies suspected of possible corruption or manufacturing problems. The FDA found that four firms had misrepresented information to the FDA on their abbreviated new drug applications (ANDA), and eight firms had deviated from approved manufacturing procedures. To date, these investigations have led to 54 drug recalls, three ANDA withdrawal actions covering 29 products, one voluntary product recall, and several referrals for criminal prosecution to the Department of Justice. • A Cross-sectional Inspection of the Industry. An additional 20 firms were inspected on the basis of ANDAs held by each company and the availability of samples to verify that bioequivalency tests were performed honestly. The FDA discovered one case of fraud and two cases of manufacturing violations.
Summarizing his report to the committee, Young said, "In general we are cautiously reassured, since we have seen no evidence to date indicating that generic medications now in use pose a serious safety threat." @
Dingell Cites Problems While the agency's finding that most generic drugs are safe and effective may ease the minds of pharmacists and patients, Subcommittee Chairman John D. Dingell (D-Mich.) reported that more work needs to be done to ensure the quality of prescription drugs. Dingell cited three problems: • The generic drug approval process still needs fine-tuning. Scarce resources, low morale, and bureaucracy have kept the generic drug process in "disrepair," and "unless the system and personnel are completely reformed, the arbitrariness that led to corruption will remain," he said. • The Department of Health and Human Services has not taken decisive action against all the companies that were found guilty of providing falsified data or other wrongdoing. Companies have been allowed to continue selling products even though questions remain about their credibility. • Congress has not yet received a legislative proposal to address the .fraud and corruption in the generic drug approval process. ''We have repeatedly heard inadequacies in the statutory framework used as an excuse, but no initiatives have been forthcoming," Dingell said... '~t some point, talk must give way to action." The committee is expected to release a report with legislative recommendations early in1990.
American Pharmacy, Vol. NS30, No. 1 January 1990/14
Legislation & Regulation
Halcion Found Safe by FDA; New Labeling Requested he most widely prescribed sleeping agent in the world, Upjohn T Co.'s Halcion, was found safe for most patients by an advisory committee of the Food and Drug Administration (FDA) in September. The committee urged stronger labeling to explain more clearly what side effects some patients might expect. The FDA investigated Halcion after receiving reports of seizures, amnesia, hallucinations, personality disorders, and other side effects. Some reports linked Halcion, a benzodiazepine hypnotic, to violent behavior. In a lawsuit against Upjohn, a 58year-old Utah woman charged that Halcion made her shoot her mother and made her lose all memory of the act. Two physicians testified that Halcion contributed to the woman's violent behavior, and a judge dismissed murder charges against her. Upjohn contends that the woman was taking other drugs
at the time and that Halcion wasn't to blame. There have been attempts to link Halcion to another murder and another attempted murder. Paul Leber, director of the FDA's Neuropharmacological Drug Products Division, said there was little or no evidence linking Halcion to the murders or to other violence. "Much of the alarm caused by reports of these incidents is not borne out by what the committee has seen," he said. "There is no emergency, and we don't see a public health hazard. The vast majority of people who use these drugs don't have anything go wrong." The committee recommended that physicians receive a stronger, more detailed warning stating that Halcion might be associated with an increased risk of amnesia. A package insert or other literature for patients should be developed saying that Halcion and other benzodiaze-
pine hypnotic sleeping pills are associated with "traveling amnesia," a condition much like jet lag in which the effect of a sleeping pill taken before ~ir travel lasts longer than expected, virtually incapacitating the traveler after the trip. The literature for patients about this reaction would also apply to the other two drugs in Halcion's class: Restoril, made by the Sandoz Pharmaceuticals Corp., and Dalmane, made by Hoffmann-La Roche, Inc. Leber said it would probably take at least six months for the FDA and the industry to work up drafts of the revised labeling and patient information for the committee to review. The committee is also considering whether to allow Upjohn to expand the market for the antianxiety drug Xanax, its leading revenue producer, to permit its use to treat panic disorders. ®
Young Assumes Nevv Post at HHS
F
rank E. Young, who resigned as Commissioner of the Food and Drug Administration (FDA) November 13, is assuming the newly created position of deputy assistant secretary for health/science and environment at the Department of Health and Human Services (HHS). HHS has named James Benson, an 18-year veteran of the agency, as interim FDA commissioner. In his new job, Young will be responsible for identifying and analyzing technological developments that impact the nation's health care system. He will also help coordinate the development and use oftechnology, nutrition, and food safety within the Public Health Service. Rumors of Young's impending departure had been circulating since the first generic drug scandals hit the FDA last summer. The agency began its search for a replacement several weeks before Young an-
nounced his resignation. Most federal officials believe that Young, who had held the position since 1984, was forced out by the Bush administration, which was displeased over the generic drug scandals that led to questions over the safety of generic drug products. But John D. Dingell (D-Mich.), head of the congressional committee investigating the generic drug scandals, believes that Young did an admirable job and instead blames the policies of the Reagan administration. "Frank Young's intentions were good, and he did his best when problems were brought to light. But he was handicapped by both the budgets and attitudes of an administration that let the agency go to seed," Dingell said. Young, who was the keynote speaker at the APhA/Academy of Pharmaceutical Research and Sci-
American Pharmacy, Vol. NS30, No.1 January 1990115
ence End-of-Summer Science Symposium in both 1989 and 1988, is credited with speeding the process of testing and approving potentially lifesaving drugs under investigation, specifically drugs for AIDS. ®
PRESERVATION
PLAN ON IT Write:
National Trust for Historic Preservation Department PA 1785 Massa,c husetts Ave., N.W Washington, D.C. 20036
15