Global Insight Perspective | |
Significance | The FDA's internal communication reveals greater opposition from senior officials over favouring pre-emption. The documents refer to the officials' views in 2003-05 when drug labelling rules were undergoing changes. |
Implications | The regulator has also failed to keep up with action dates of several drugs this year increasing uncertainty of new product launches for drug makers. This has affected prospective revenue plans of major drug makers. |
Outlook | Drug labelling rules in August 2008 have been strengthened as a consequence of the current criticisms but coupled with the PDUFA concern, drug makers can expect greater scrutiny resulting in delays over drug approvals in the short term. |
Pre-Emption
Officials at the U.S. FDA had expressed strong opinions against the agency's decision to favour pre-emption. According to internal documents published in a report by the Committee on Oversight and Government Reform, there were objections to the pre-emption language contained in the preamble to the 2006 Physician's Labelling Rule. The opposition came primarily from Dr John Jenkins, director of the Office of New Drugs in the Centre for Drug Evaluation and Research (CDER) who observed that the pre-emption clause is based on a "false assumption that FDA approved labelling is fully accurate and up to date in a real time basis". Furthermore, the official also observed that the inclusion of the sentence: "FDA regulation of the dissemination of risk information in prescription drug and biological product labelling thus effectively operates as both a floor and a ceiling'', is not agreeable as drug makers would add new information without prior FDA approval. He also questioned the argument that liability concerns would lead to decreased product innovation or withdrawals, citing there was no data to support the contention. Other officials who have indicated their view against the inclusion of the pre-emption section are Dr Steven Galson, acting director of CDER and Dr Rachel Behram, deputy director of CDER's Office of Medical Policy.
PDUFA Deadlines
The FDA is under pressure to explain the missed deadlines related to new drug applications (NDAs) according to the Prescription Drug User Fee Act (PDUFA). Bloomberg reports that so far the regulator has missed 15 deadlines but does not offer any comparison to last year's figures. However, Dr John Jenkins has acknowledged that delays have occurred with respect to these deadlines, primarily due to shortage of staff and the added responsibilities on the FDA following the implementation of tougher drug safety rules. The source lists Daiichi-Sankyo (Japan) and Eli Lilly (U.S.)'s Prasugrel, Schering Plough (U.S.)'s asenapine, GSK (U.K.)'s Promacta and Takeda (Japan)'s alogliptin among others who have been affected by the regulator's delay. The FDA has however, maintained that PDUFA dates are treated seriously and that they are trying to adhere to them.
Outlook and Implications
The revelation of opposition from top officials in the FDA on the matter of pre-emption may be viewed as potential support for introducing norms that expose drug makers to further product liability suits. Also, the Oversight committee is alleging the federal government's "interference" in enforcing pre-emption law. The emergence of further arguments against favouring pre-emption is significant in the context of the Wyeth versus Diana Levine case which is due to be heard at the Supreme Court this week. It is notable that 47 U.S. states have expressed their support to extending the US$6.8-million damage award to Diana Levine.
On the missing of PDUFA deadlines, although the comparative numbers are not available, it is clear that the FDA's action dates for new drugs have not been meet at the same level as previous years. The fact that the PDUFA deadlines are non binding is seen as one of the reasons for the FDA's slow approach particularly at a time when the agency is going through restructuring and being given additional responsibilities. In the past two years, the regulator has faced several criticisms over its operations primarily on drug safety. With responsibilities such as adverse event reporting, post-marketing surveillance and increasing scrutiny over products manufactured in foreign locations such as India and China, the agency is fairly stretched in its operations. The restructuring of the operations also includes establishing new personnel positions and filling current positions but it is clear there is still a long way to go before the entire operation is streamlined and issues such as PDUFA deadlines are met. In the short term though, drug makers will be facing delays and increasing scrutiny of their NDAs.