News Briefs
FDA approves generic omeprazole
First competitor with Prilosec
On Nov. 1, the Food and Drug Administration (FDA) approved the Kremers Urban Development Co. (KUDCo) abbreviated new drug application (ANDA) for 10 mg and 20 mg omeprazole delayed-release capsules. This approval will permit the first marketing of a generic omeprazole product to compete with AstraZeneca LP’s blockbuster Prilosec for the treatment of certain gastrointestinal conditions.
KUDCo’s ANDA is not the first approved generic omeprazole; however, it is the first approval of a generic omeprazole that does not infringe patents held by AstraZeneca. The FDA approved an Andrx Pharmaceuticals’ ANDA for omeprazole in November 2001, but Andrx has not been able to market its generic omeprazole because of patent infringement concerns.
Andrx and Genpharm shared eligibility for 180-day exclusivity for generic omeprazole. Under an agreement with KUDCo, Andrx and Genpharm have relinquished their eligibility for exclusivity to permit FDA approval of other generic omeprazole products. As defined by the agreement, KUDCo will share a percentage of its profits with Andrx and Genpharm, with each company’s share reducing from 15% to 9% to 6.25% over a period of time, based upon a number of factors.
Study says schools often stray from set guidelines
Few contracts require results to be published
Academic institutions routinely engage in industry-sponsored research that fails to adhere to International Committee of Medical Journal Editors guidelines regarding trial design, access to data, and publication rights, say researchers in a study published in the Oct. 24 issue of the New England Journal of Medicine.
Last winter, researchers from Duke University Medical Center and the Duke University School of Law in Durham, NC, interviewed officials at 108 U.S. medical schools about provisions in their institutions’ agreements with industry sponsors of multicenter clinical trials. The researchers also asked a subgroup of the respondents about coordinating-center agreements for such trials.
Some of the study findings include:
- Only 10% of contracts covered how data is collected and monitored, and only 5% covered how data is analyzed and interpreted.
- Less than 1% of contracts guaranteed that results would be published and that an independent committee would have control over that. However, 40% of contracts addressed editorial control of manuscripts.
- Only 1% of contracts required an independent board to monitor patient safety.
"Our findings suggest that a re-evaluation of the process of contracting for clinical research is urgently needed," the researchers say.
Warnings strengthened by urokinase reintroduction
The Food and Drug Administration and Abbott Laboratories have announced the reintroduction of urokinase (Abbokinase) for use in the lysis of massive pulmonary emboli and pulmonary emboli accompanied by unstable hemodynamics. The "warnings" section of the labeling has been strengthened to include post-marketing reports of anaphylaxis, other infusion reactions, and class information regarding the potential for cholesterol embolization. The "adverse reactions" section of the product labeling reflects the analysis of post-marketing safety data.
Complications related to bone cement, FDA says
The Food and Drug Administration has notified health care professionals about complications related to the use of polymethylmethacrylate bone cement to treat osteoporotic compression fractures of the spine using surgical procedures known as vertebroplasty and kyphoplasty. Reported complications, such as soft tissue damage and nerve root pain and compression, are related specifically to the leakage of bone cement. Other reported complications include pulmonary embolism, respiratory and cardiac failure, and death. For more information, see www.fda.gov/medwatch/SAFETY/2002/safety02.htm#bone.
In the year 2020: Shortfall of even more pharmacists
15 more pharmacy schools will be needed
A shortfall of as many as 157,000 pharmacists is predicted by 2020, according to the findings of a conference sponsored by the Pharmacy Manpower Project, a nonprofit corporation consisting of major national pharmaceutical professional and trade organizations.
The recent three-day conference was attended by 24 individuals from community, hospital, and managed care sectors of pharmacy practice; colleges and schools of pharmacy; industry; and government. Complete findings are detailed in a final report titled, "Professionally Determined Need for Pharmacy Services in 2020."
Conference participants examined the services patients need and, from those estimates, projected the number of pharmacists required to deliver the needed services. The final report made a distinction between the mechanical functions of filling a prescription and patient-care activities. The resulting shortfall of 157,000 pharmacists breaks out as 100,000 full-time pharmacists for order fulfillment (compared with 136,400 currently); 165,000 pharmacists to provide primary care services (30,000 currently); 130,000 pharmacists to provide secondary/tertiary care services (18,000 currently); and 22,000 for other nonpatient-related activities (12,300 currently).
These numbers are estimates of the need for pharmacists, not projections of actual demand, which is determined by the marketplace. Conference participants acknowledged that the estimates may not translate into jobs for pharmacists, but they pointed out that the need for the pharmacists’ functions would not go away.
Results of the conference also supported the need to increase capacity in pharmaceutical education and practice. The conference forecasted a need for 3,250 pharmacy-trained faculty and administrators by 2020, compared with 2,600 currently, concluding that 15 additional pharmacy schools will be needed.
FDA approves generic omeprazole; Study says schools often stray from set guidelines; Warnings strengthened by urokinase reintroduction; Complications related to bone cement, FDA says; In the year 2020: Shortfall of even more pharmacists.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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