Commission Seeks Streamlining of Federal Drug Approval Process

Commission Seeks Streamlining of Federal Drug Approval Process

1-N®~~-------------------------------------- Commission Seeks Streamlining of Federal Drug Approval Process The long-awaited report of the Congressio...

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Commission Seeks Streamlining of Federal Drug Approval Process The long-awaited report of the Congressional Commission on the Federal Drug Approval Process, released April29, commends the Food and Drug Administration for its performance in reviewing drugs but calls for several dozen changes that would enhance the speed and quality of the drug approval process while maintaining the existing level of public health protection. Established last year by Reps. James H. Scheuer (D-NY) and Albert Gore Jr. (D-TN) after a General Accounting Office report documented a serious drug lag in the United States, the commission unanimously agreed that no major changes are needed in the Food, Drug and Cosmetics Act and reaffirmed the value of the 1962 amendments to the FD&C Act which require proof of effectiveness as well as safety before a drug can be marketed. Essentially, the commission called for a simplification and streamlining of the drug approval process, clarification of the standards of evidence required to approve new drugs, greater use of outside advisers and their use earlier in the approval process, better resolution of disputes between FDA and a drug sponsor, and a lessening of the adversarial relationship between FDA and pharmaceutical companies. The commission's report was released at a press conference at which commission members did not say how much time would be saved by implementing their recommendations. Commission member Louis Lasagna of the University of Rochester said that by tackling the approval process in a number of places, the "savings in time can be substantial. The commission broke the drug approval process into three distinct components for the sake of making recommendations: the investigaII

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tiona! new drug (IND) process, the new drug application (NDA) process, and FDA management issues. FDA's response to at least some of the commission's findings was apparent in a press release issued the day before the report was made public, indicating that the agency was already working to implement some of the commission's recommendations. Scheuer lauded FDA for "embracing the spirit of the report. [It] undertook to start changes before the ink was dry on the commission's report. The eight core recommendations of the committee were: • Preclinical testing requests should be simplified so that more new drugs can be tested in humans, consistent with the protection of human safety. • The safety and efficacy standards for approving new drugs should be clarified by regulation. Proof of effectiveness should be accepted through one or two studies that are adequate individually or through the accumulation of data from several studies that, taken together, provide substantial evidence. • NDA submissions should be greatly streamlined. Summaries of data should replace individual case reports. • Expert advisers should be used much more and should be available to advise on the investigational development of a new drug and its evaluation by FDA. • Congress and the administration should ensure that FDA has sufficient and stable resources to review and act promptly on INDs and NDAs. • An ombudsman function should be established in the FDA commissioner's office to ensure timely and equitable resolution of disputes between FDA and drug sponsors. • FDA should establish a comII

puter-based system for tracking NDAs. FDA senior staff should regularly review the status of NDAs and report appropriate information to the commissioner. • To ensure the participation of the best-qualified outside expert advisers in the drug approval process, the FDA commissioner should request from the Justice Department a less restrictive interpretation of the federal conflict-of-interest statutes. Among the other recommendations of the committee: • Studies undertaken by pharmaceutical firms involving previously approved drugs should generally be regulated in the same manner as clinical development studies. • A simplified procedure should be devised to permit compassionate or emergency therapeutic use of drugs in the IND process. • Drugs should generally be considered for approval based on the drugs' safety and effectiveness per se. Only in unusual cases should relative safety affect approval decisions. • The FDA commissioner should seek the assistance of leading professional societies, universities and other appropriate bodies to gain the services of qualified consultants in the fields of pharmacology and therapeutics. • All prescription drug products, including generic versions of pioneer products, should be subject to premarket approval by FDA. • FDA should require in vivo bioequivalency testing for all generic versions of post-1962 drugs except when clearly unnecessary or technically impossible. • FDA should encourage all review personnel to conduct "timely, forthright and even-handed discussions" with drug sponsors throughout the approval process. Formal communications should be limited to situations that require formality. -Patricia A. Mullan 11

~®~~----------------------------------Twice Yearly Dating Endorsed The Joint Commission on Pharmacy Practitioners recently stated its support of uniform semiannual expiration dating in January and July for all prescription drugs. This action was taken to assist pharmacists in inventory control and to assure that medications are dispensed or returned before the expiration date approved by the Food and Drug Administration. Recognizing the difficulties associated with uniform semiannual dating for products with relatively short shelf lives, the commission will urge manufacturers to use the January and July dates to the extent possible, and especially for those with a shelf life of at least 60 months. Many manufacturers have already adopted the January and July dating on many of their products.

Health Education Resource Available A bibliographic data base of information on health education methodologies and programs is available to health educators through the U.S. Department of Health and Human Services' Center for Health Promotion and Education. To ensure the comprehensiveness of the data base, the center is seeking literature sources and program descriptions to enter into the system. Topics of interest include school, patient, community, and occupational health education programs; health education methodologies; professional education and training in health education; health education as it relates to basic prevention and health risk reduction; health education research and evaluation; and international health education activities. Complete information concerning the format of submitted information may be obtained from: The Center for Health Promotion and Education, Attention: Current Awareness in Health Education, P.O. Box 57369, Washington, DC 20037. 12

California's Fight Against Pharmacy Crime The California Pharmacists Association has published a new brochure on pharmacy security as part of its growing efforts to halt pharmacy crime. The brochure, entitled "Give Pharmacy Crime a Hard Time," follows on the heels of the release of a poster now prominently featured in most California pharmacies. CPhA Executive Vice-President Robert C. Johnson noted that pharmacy crime "seems to be getting worse [and] as unemployment and the recession continue, pharmacists can expect even greater problems." The brochure borrows some suggestions from a manual published by Smith Kline and French, combined with suggestions from Captain Tom Stark of the Sacramento Police Department, on how to prevent crime in the pharmacy. The brochure is available free by sending a stamped, self-addressed envelope to: CPhA, 555 Capitol Mall, Suite 645, Sacramento, CA 95814.

Research Center on Aging Formed After years of involvement in educational and service programs for the elderly, the University of Maryland School of Pharmacy is establishing a Center for the Study of Pharmacy and Therapeutics for the Elderly, a research organization composed of representatives of all departments of the school. Formed in response to the dearth of reliable scientific data on drugs in the elderly, the center will address: • The influence of dosage forms on drug action and the need for specific dosage forms for elderly patients; • The interaction of nutrition and

drug action; • Age-related changes in pharmacodynamics and pharmacokinetics; , • Drug toxicity, adverse drug ef- . fects and prevention or amelioration ! 1 of these effects; • Development of animal models : and analytical methods to study drug action in elderly patients efficiently; • Drug-taking behavior of elderly 1 patients . For further information, contact: Peter P. Lamy, School of Pharmacy, , University of Maryland, Baltimore ;

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21201; (301) 528-7613.

Diabetes' Toll

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Diabetes continues to take an in- . creasing human toll as an estimated j 1 in 20 Americans are now affected 'I by the disease, according to figures ; compiled by the National Institute I of Arthritis, Diabetes and Digestive I and Kidney Diseases. There are 5.7 ' million known diabetics in this country plus another 5.7 undiag- 1 nosed cases. / Diabetes causes almost 50% of all disorders that require foot and leg amputations among adults, 20 % of : all cases of kidney failure, and 15% of all blindness; 25 % of diabetics have heart disease. Annually, di- : abetes accounts directly for 34,000 deaths and indirectly for 100,000 deaths in the United States, placing this country among the five nations with the highest diabetes-related 1 mortality. 1

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