Will Transatlantic Regulatory Cooperation Meet Expectations? - Pharmaceutical Technology

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Will Transatlantic Regulatory Cooperation Meet Expectations?
There has been increasing cooperation between the EMA and the FDA in recent years, and this looks set to continue in the future. However, with both agencies having been criticised for their approval processes and safety monitoring, will greater regulatory harmonisation be beneficial to industry and accepted by consumers?

Pharmaceutical Technology Europe
Volume 22, Issue 11

Agency criticisms

In the US, there has been criticism from the pharma industry that the FDA is more conservative than the EMA when it comes to approvals. The FDA has flatly denied this accusation, despite a recent slowdown in product approvals, with some FDA officials adding that the analysis of their decision-making is flawed because it places too much emphasis on the absolute numbers of approvals in the US compared with previous years. In contrast, they believe greater attention should be paid to the quality of the applications themselves.7,8

The pharma industry's criticism of the FDA is ironic because the agency frequently finds itself under fire from the US media and the public for being too "industry-friendly". For example, the agency has recently been criticised for having approved Pfizer's Mylotarg (gemtuzumab) for acute myeloid leukaemia (AML) based on preliminary data.9 Mylotarg had been approved under the FDA's accelerated approval regulations, but was withdrawn from the market by Pfizer earlier this year following disappointing results from ongoing trials, as well as safety concerns. This type of criticism is a worry for the FDA, which has been trying to rebuild its reputation with the US public following the scandal surrounding Vioxx (rofecoxib) in 2004.10

Meanwhile in Europe, the EMA also faces much criticism and is often touted as not being as efficient and as transparent as its US counterpart. According to a report issued in 2007, over the period 2000 to 2005, of the 71 drugs approved by both agencies, 47 were approved more quickly by the FDA than by the EMA.11

As with the FDA, the EMA has also received criticism over the way it has handled product approvals. In May 2010, a Lancet editorial attacked the EMA for not releasing additional safety information on Roche's acne drug Accutane (isotretinoin).12 The EMA initially responded by stating that it was under no obligation to release serious adverse reaction reports; however, following intervention from the European Ombudsman, the EMA decided to comply.13

The author says...
Moving forward, both the EMA and the FDA will have their work cut out for them regarding their intent to provide parallel scientific advice to companies. Because of limitations in resources, both agencies say they intend to concentrate on breakthrough drugs or important safety issues in areas that have been identified as "clusters of interest".14 The process will be voluntary and is generally expected to be initiated at the request of a sponsor. However, with the decision-making processes of both agencies having been called into question on occasions, finding a balance between the two systems may be problematic for the agencies. For compounds at an early stage of development, companies also worry whether the advice will still be valid by the time the product is ready for a formal regulatory application. A separate issue is how the cooperative efforts of the EMA and the FDA will be perceived by the public. Industry critics — already unconvinced by the rigour of the approval processes currently in existence — may feel that companies are being given an easier ride through joint regulatory measures.

At present, both agencies are under fire regarding the approval of GlaxoSmithKline's Avandia (rosiglitazone).15,16 While the FDA has been criticised for not having enough resources to have conducted a thorough evaluation of the trial results, the EMA has been described as being too reliant on data summaries provided by the companies marketing the products. In September 2010, the EMA recommended suspension of Avandia's marketing authorisation in the EU, whereas in the US, the FDA decided to significantly restrict the drug's use.


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