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Risk management is forgotten as FDA reform struggles through Congress Posted 22/06/2012

FDA’s authority on new drug approvals and post-marketing reports was last updated in 2007, when Congress passed the FDA Amendments Act (FDAAA), and this time the deadline is 30 September 2012 for the Prescription Drug User Fee Act (PDUFA), made law in 1992. It is generally accepted that FDA should also amend the Risk Evaluation and Mitigation Strategies or REMS programmes. This is important for generics, since as part of REMS originator companies have to provide samples of their products.

REMS are being used for the wrong reasons
FDA’s proposals are restrained in 2012, as the agency is well aware that Senate and Congress are Republican-dominated at present and will not accept major regulation of business activities. However, under REMS, companies have to provide samples of the drugs they market for development and testing. An amendment approved in the Senate has supported the view of the Generic Pharmaceutical Association that ‘unfortunately, these REMS programmes are being used to block access to comparator products to halt generic drug and biosimilar product development and are thereby blocking fair and timely generic drug and biosimilar competition.’ Generics companies complain that ‘brand-name drugmakers have been using the strict distribution provisions of REMS regulation as an excuse not to provide samples for development and testing’ [1].

At present the Senate has adopted Section 1131 while the text before Congress contains a more lenient amendment. In it, FDA must respond to Citizen’s Petitions that refer to an application for a generic drug or biosimilar. The agency would be required to respond in 150 days, not 180 days, suggesting a generic or biosimilar medication might be approved 30 days earlier than otherwise.

The Congressional Budget Office recently estimated that the amended Section 1131 of the Senate bill, along with other provisions, ‘would reduce barriers to market entry for lower-priced drugs arising from certain labelling exclusivities, would reduce direct spending for mandatory new drug approvals and post-marketing reports by US$753 million’ between 2013 and 2022.

FDA has so far not established a standard REMS format
All the discussions (‘horse trading’, as the Americans call these negotiations) are concentrating on what the pharmaceutical industry might get out of new rules. What seems to have been lost sight of, is post-marketing safety monitoring, originally the main purpose of this section of the rules. FDA is authorised to require REMS when they are necessary to ensure that the benefits of a new drug outweigh the risks. FDA also promises to explore strategies to standardise REMS, when appropriate, to reduce the burden of implementing REMS on practitioners, patients, and others in various healthcare settings. In the absence of a template, some drug companies are creating REMS as marketing tools. 


1.  GaBI Online - Generics and Biosimilars Initiative. Generics makers cannot gain access to some brand-name drugs [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Jun 22]. Available from: www.gabionline.net/Generics/News/Generics-makers-cannot-gain-access-to-some-brand-name-drugs

Source: CBO, GPhA, P&T

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