As the world's largest pharmaceutical market, the US is frequently targeted by companies for initial drug launches, and this
means bending over backwards to convince the FDA that the product is safe and effective. As such, the FDA has a tremendous
task on its hands in reviewing the huge amount of regulatory dossiers it receives as submissions, as well as ensuring the
safety of products that have already reached the market.
In meeting its regulatory commitments, the FDA can find itself increasingly at odds with pharma companies, which are under
pressure to launch as many drugs as possible and to grow their businesses from sales of these products. As the new political
administration, under President Barack Obama, has promised a new direction for US healthcare,1 it is inevitable that the FDA will undergo significant change. However, although the agency and pharma have often been at
loggerheads, it is the criticism of the general public regarding failings in drug safety that will have a greater impact on
the future of the FDA.
A reorganization of the regulatory body will have huge implications for the pharmaceutical and biotech industries operating
in the US, and will also influence activities in other markets because of the growing interactions between the FDA and its
foreign counterparts. In particular, the next few months at the agency will be of great interest to all firms planning drug
launches because the regulatory landscape could be about to be revolutionized.
The author says...
The blame game
There is internal debate within the pharma industry concerning its productivity and innovation in R&D. Year by year, new drug
output has steadily declined, despite continuing unmet medical need in a number of important disease areas. The global pharma
industry continues to increase its investment in R&D — with an estimated spend of $70 billion (51.7 billion) in 20072 — but the performance of the sector in translating this investment into innovative products remains questionable. Critics
of the pharma industry have argued that companies rely too heavily on line extensions and working on new formulations of existing
products rather than concentrating their efforts on true innovation in R&D. This has led to companies submitting weaker regulatory
dossiers, which in turn has restricted the number of drugs reaching the market.
Some companies have blamed regulatory agencies, such as the FDA, for the decline in new drugs on the market. In 2007, the
FDA approved 65 original new drug applications (NDAs), the least since 1999.3 Furthermore, the ratio of NDAs approved to NDAs submitted has dropped from the 76% level of 2006 to less than 60%.4 Many companies believe that the FDA has been excessively bureaucratic, which has slowed the review process.5 One 2008 media report claimed that 15 additional new drugs could have been on the national market if the FDA had been more
efficient in conducting its reviews.5 The FDA has a target of meeting 90% of its new drug approval timelines for review, but although full 2008 performance data
have not yet been released, the agency has already indicated that it is unlikely to reach this goal.6
Despite these criticisms, the FDA insists it has not changed the way in which it approaches regulatory review. Recently, an
agency spokesman stated that the rate of NDA approvals to submissions remained steady at approximately 80% from 1997 through
to 20053 — although independent media reports have cited a decline after this period.4