Just a Matter of Time

Implications: Overseas manufacturing controls for both APIs and finished drug products will need to be improved and the FDA will closely monitor compliance in an increased fashion. Drug regulation itself is not likely to change, but more inspections and more thorough review of DMFs and information submitted in support of late-stage INDs and NDAs/BLAs will occur. The FDA has been lax in assuring that the veritable explosion of outsourcing of raw material and API manufacture to third-world and emerging nations has been closely monitored for compliance with purity, potency and other requirements.

Analysis: The strong pressures for control of drug pricing by goernment, insurers and healthcare containment advocates have led to a movement towards outsoucing of raw materials, API and dinfished drug products to India, China and other countries outside of the US and Europe. The controls on quality have not followed suit in intensity, either by the pharmaceutical firms or the FDA. This has led to an increased probability that contaminated or lower quality material may appear in at least some batches of pharmaceuticals to which patients may be exposed. The laws and regulations to control this situation are in place; the FDA's priorities have, however, not included stepped up policing of this situation to assure product quality. The will is there, but the resources and finances are limited. Generic manufacturers might be seen as being more vulnerable to the negative effects of this situation; however, the heparin episodes have shown that even major pharma companies have been attempting to minimize their costs by moving to somewhat questionable suppliers. The answer to this qundary is more internal inspections and audits of raw materials and API by firms themselves as well as stepped up compliance by the FDA. The recent move to place FDA offices in China is a step in the right direction.