Accounting for Differences Among Patients in the FDA Approval Process

Abstract:Objective:To assess perceptions and opinions about the FDA approval process for disease modifying therapies (DMT) in people living with multiple sclerosis (MS).Methods:People living with MS were invited to complete a web-based survey of their perceptions of the FDA role and process for approval of MS medications. The survey asked about the role of the FDA, factors involved in the approval process, which voices should represent those with MS in deliberations about drug approval, and the level of comfort with uncertain safety of newly-approved therapies.Results:3533 respondents met inclusion criteria for data analysis. Most respondents appeared to understand the role of the FDA, although only half understood a fundamental FDA role: balancing the risks and benefits when considering drug approval. Significant differences were observed in many areas between those who have and have not tried DMTs. Comfort with uncertainty was associated with several factors relating to side effects and benefits thought important for the FDA to consider. Most respondents reported that people who participated in the medication’s clinical trial were particularly able to represent people living with MS.Conclusion:Perceptions regarding the FDA and views of who should represent people living with MS varied between those who have and have not tried DMT. There is variability in personal values that should be recognized and taken into account when considering regulatory responsibilities. Interventions are needed to address educational gaps regarding the mission and trustworthiness of the FDA as an oversight body.

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The Twenty-Five-Year FDA Approval Controversy

Contraceptive Risk ◽

10.18574/nyu/9781479876990.003.0003 ◽

2017 ◽

Author(s):

William Green

Keyword(s):

Population Control ◽

Obstetrics And Gynecology ◽

Marketing Approval ◽

Approval Process ◽

Control Programs ◽

Drug Risk ◽

Fda Approval ◽

Political Controversy ◽

Long Acting ◽

Risk Acceptability

Judith Weisz's story of the politics of drug risk management shifts its focus to Depo-Provera's lengthy FDA marketing approval process. Here her story explores the scientific and political controversy over the FDA's assessment of the drug's risk and its policy judgments about the risk acceptability of its marketing approval. The controversy was dominated by the fear that the drug could cause breast, endometrial, and cervical cancer, and by Depo-Provera's uniqueness as a long-acting contraceptive and its use in international population control programs. The controversy began when the FDA relied on its Obstetrics and Gynecology Advisory Committee to grant the drug limited marketing approval in 1974, which it withdrew after congressional criticism, and then, following an intra-agency review, disapproved the drug for general contraceptive marketing which, once again, brought congressional scrutiny because of its impact on international family planning programs. An FDA Public Board of Inquiry, convened at Upjohn's request and chaired by Judith Weisz, conducted an intensive scientific assessment of the drug's animal and human studies at its 1983 hearings and then made a recommendation, accepted by the FDA in 1986, to disapprove the drug for general contraceptive marketing.

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