Drug innovation and approval

These incidents have prompted the FDA to impose stricter requirements for drug assessment and approval. The observers of the doldrums in pharma innovation have raised the question as to whether new criteria applied are a root cause for the slump in new drug launches. Contrary to common belief, the FDA has not become more restrictive regarding New Drug Applications... 

Frantz S. (2004) 2003 approvals A year of innovation and upward trends. Nat Rev Drug Discov 3 103-105. 

We used the cumulative number of drugs with NMEs approved and launched in Taiwan to measure pharmaceutical innovations. The annual number of NMEs introduced into Taiwan between 1985 and 2002 followed cyclic patterns (Fig. 13.1). In 1985, 95 NMEs were introduced in this market. This number decreased to 52 and 49 in the next two years, but increased subsequently. In 1995 only 15 NMEs were introduced, possibly reflecting delays in approvals caused by the transition from the then-existing health care financing system to national health insurance in Taiwan in that year. ... 

Since there has been disagreement over the meaning of the terms safe and effective, this paper will use new chemical entities (NCE s) approved for marketing by FDA as the measure for drug innovation — the more approved NCE s per R D dollar, the more productive drug research is, if one accepts this definition. It appears to be a commonly accepted definition (1). 

The criticism appears to at least partially negate Peltzman s conclusion that the costs of the 1962 Amendments exceed their benefits — costs in Peltzman s study refer to "effective" drugs that do not reach the U.S. consumer and benefits refer to "ineffective" drugs kept off the U.S. market. Nevertheless, the speed at which drugs are granted market approval and the impact of FDA and its authority on drug innovation (the two parameters of the "drug lag") are still viable issues. 

It is important to note that generic drug products can be developed and approved more quickly than innovator drugs, because clinical trials are not typically required. A 505(b)(1) or 505(b)(2) NDA holder may delay approval of an ANDA due to patent or exclusivity considerations, however. These issues, however, while described briefly later, are beyond the scope of this chapter. 

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