Are drug regulators really too slow?

Marciniak, Thomas A.; Serebruany, Victor L.

doi:10.1136/bmj.j2867

Cited by 3 publications

(3 citation statements)

References 2 publications

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“…These programmes are intended to meet the expectations of drug manufacturers and patients, the former eager to launch new drugs promptly to maximise the return on investment and the latter to have access to potentially innovative therapies as soon as possible. Expedited programmes implemented by the FDA provide shorter overall review times than standard ones, and account for the reportedly faster process than at the EMA …”

Section: Introductionmentioning

confidence: 99%

Food and Drug Administration vs European Medicines Agency: Review times and clinical evidence on novel drugs at the time of approval

Joppi

Bertelè

Vannini

et al. 2019

Brit J Clinical Pharma

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The Food and Drug Administration (FDA) and European Medicines Agency (EMA) now have expedited review procedures for new drugs. We compared the review times of medicines licensed by the 2 agencies and explored differences in the evidence submitted. In 2015-2017 the FDA licensed 113 drugs, 66 of which reached Europe. The median review time was longer at the EMA than FDA and was shorter for drugs undergoing FDA-expedited programmes compared to the same drugs approved by the EMA through the standard procedure. We identified differences regarding the evidence submitted to the 2 regulators for 7 drugs. The greater use of expedited programmes by the FDA and administrative time at the European Commission mainly explain the later access of new drugs to the European market. The additional evidence submitted to the EMA is generally scant and limited to a few drugs. K E Y W O R D S drug regulation, health policy, therapeutics 1 | BACKGROUND Regulatory agencies face constant pressure to speed up the development, review and approval of drugs for serious diseases. Both the Food and Drug Administration (FDA) and European Medicines Agency (EMA) support clinical drug development and accelerated review and authorisation procedures (Box 1). 1 These programmes are intended to meet the expectations of drug manufacturers and patients, the former eager to launch new drugs promptly to maximise the return on investment and the latter to have access to potentially innovative therapies as soon as possible. Expedited programmes implemented by the FDA provide shorter overall review times than standard ones, 2 and account for the reportedly faster process than at the EMA. 3-6The earlier application and shorter review times at the FDA compared to the EMA may offer the European agency the possibility to assess the same drugs on the basis of more comprehensive information. To test this, we first assessed the delays in the application dates of the novel drugs-namely, new molecular entities and original biologic agents-licensed by both FDA and EMA, and compared their review times. Then we explored the differences in the evidence available at the time of EMA approval of medicines already licensed by the FDA through expedited programmes. | METHODSWe identified the drugs approved by the FDA from January 2015 through December 2017 using 3 reports published by the agency. [7][8][9] We extracted the date of approval, information on the type of authorisation procedure, and information on the evidence submitted in the marketing authorisation (MA) application from the Drugs@Fda database. 1,10 Review times in USA were calculated as the number of days elapsed from the Investigational New Drug application to the first FDA approval. Investigational New Drug application dates were obtained from FDA documents and administrative correspondence.We classified applications as either expedited or non-expedited procedures (Box 1).

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Section: Introductionmentioning

confidence: 99%

Food and Drug Administration vs European Medicines Agency: Review times and clinical evidence on novel drugs at the time of approval

Joppi

Bertelè

Vannini

et al. 2019

Brit J Clinical Pharma

View full text Add to dashboard Cite

show abstract

“…39 40 However, failure to register or fund a drug does not necessarily mean the regulatory or reimbursement systems are cumbersome or unfair. 41 There may be too much uncertainty about a drug's safety or efficacy, or it may have low cost effectiveness or be unaffordable.…”

Section: Effects Of Accelerated Accessmentioning

confidence: 99%

“…[35][36][37][38][39][40][41][42][43][44][45][46][47][48][49] We therefore have to find different ways to respond. Perhaps the most obvious alternative-although it is often neglected-is to increase support for publicly funded clinical trials.…”

Section: Better Responsementioning

confidence: 99%