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At least 37 records · Page 2Linked to original sources
PubMed2003

Off-label or out of bounds? Prescriber and marketer liability for unapproved uses of FDA-approved drugs.

Professor O'Reilly's study of recent drug review legislation applies a historical and holistic view of promotion practices for unapproved uses of prescription drugs. He faults Congress for moving public health protections away from a strictly protective mode and toward assistance to drug marketers. He argues that the adverse health consequences of "off-label" promotion of drugs are not well understood, and that the 1997 amendments deserved the public health interest while expanding pharmaceutical company profits.

Consumer Organizations↗
PubMedDate not supplied

Understanding the scientific issues embedded in the generic drug approval process.

OBJECTIVE: To review the major scientific issues embedded in the generic drug approval process. DATA SOURCES: Articles indexed initially under terms such as generic medications, generic drugs, bioequivalence, and bioinequivalence. These terms were used to search indexing services such as MEDLINE, International Pharmaceutical Abstracts, CINAHL (a database of nursing and allied health literature), and Science Citation Index. Additional data sources included the Code of Federal Regulations and regulatory guidances from the Food and Drug Administration (FDA) Center for Drug Evaluation and Research. STUDY SELECTION: Performed by the authors. DATA EXTRACTION: Not applicable. DATA SYNTHESIS: Despite the fact that regulations regarding bioequivalence have been in place for more than 20 years, controversies over bioequivalence continue to arise. Consensus on many of these issues is driving the development of new FDA guidances regarding bioequivalence. Still, despite the issuance of new guidance and consensus building among scientists, many clinicians and consumers remain uninformed regarding the scientific basis for establishing bioequivalence and the generic drug approval process in general. Although some have suggested that the generic drug approval process is flawed, overall, it appears that the process works. CONCLUSION: Understanding the generic drug approval process and the issues surrounding bioequivalence is of paramount importance to both clinicians and scientists.

Drug Approval↗
PubMed2000

FDA censoring of manufacturers' postmarketing commitments in HIV/AIDS drug approval letters.

CONTEXT: Changing evidentiary standards and partial shift of the investigational phase of drug approval process to the postmarketing phase. OBJECTIVE: To determine the availability of information for independent researchers needed to examine accelerated drug approvals to determine how they differ from traditional drug approvals in the HIV/AIDS domain. DESIGN: Identification of all approved HIV/AIDS and AIDS-related conditions drugs between 1987 and 1999. Follow-up of postmarketing study requirements in the approval letters addressed to the manufacturers. SETTING: Accelerated approval has been expanded to other disease conditions in the past decade. INTERVENTION: Request of approval letters from the U.S. Food and Drug Administration for 76 regulatory actions including expanded access and accelerated and traditional approvals for 42 drugs under the Freedom of Information Act (FOIA) between September 1998 and October 1999. MAIN OUTCOME MEASURE(S): Obtainability of approval letters and uncensored postmarketing study requirements. RESULTS: Fifty-five approval letters were received. Postmarketing study commitments of manufacturers were censored in 25 letters received. We were unable to obtain uncensored copies of those approval letters as of May 2000. Censoring was associated with whether (1) the Prescription Drug User Fee Act of 1992 was applicable to the drug (odds ratio (OR) = 5.7, 95% confidence interval (CI) = 1.4- 23.7) and (2) the new drug application was for a new molecular entity or new drug formulation (OR = 4.2, 95% CI = 1.3 -13.6). CONCLUSIONS: Continued secrecy may stifle independent research and hinder health care providers and patients in making informed decisions.

Acquired Immunodeficiency Syndrome↗
PubMed1994

Who needs faster drug approval times in Canada: the public or the industry?

Over the past decade the Canadian drug approval system has come under intensive scrutiny, with the greatest amount of attention being given to the length of time required to approve new drugs. This issue has obviously also been of considerable interest to the pharmaceutical industry, and the question arises as to whether or not the concerns of the industry may be driving the proposed reforms to speed up the approval process. Both industry and government maintain that quicker approval of new drugs will ensure that Canadians have more rapid access to new medications without sacrificing safety. There are problems with these claims. The number of therapeutically important new drugs introduced annually is less than five and these are already "fast tracked," so the need to speed up approval for all products is dubious. There is also evidence that safety may be compromised with faster approvals. Industry does not need quicker approval times for its financial viability, but getting new, more expensive drugs onto the market more rapidly will increase sales and profit levels. Alternative approaches to dealing with problems such as drug approval times will only be possible when the policy-making process becomes more transparent and open.

Canada↗
PubMed1978

Analytical methodology and the interface with animal drug approval.

FDA is engaged in a systematic review of approved animal drugs to determine whether upgrading of safety data is required to provide continuing assurance that the approved uses for these drugs are safe. These reviews will be undertaken on the basis of a priority of anticipated human health significance.

Animals↗
PubMed1997

Post-approval drug research: objectives and methods.

The limitations of pre-marketing clinical trials are analyzed and the need for ongoing drug research after approval is emphasized. Rare adverse drug reactions constitute the most important but not the only question. In addition to so-called post-marketing Drug Utilization Observation studies and spontaneous event reporting systems, other pharmacoepidemiologic study approaches like comparative cohort studies and case control studies, and also randomized clinical trials, are necessary to meet the multitude of scientific objectives of post-approval drug research.

Drug Approval↗