Quality control problems have increased focus on biopharm and the role of the US Food and Drug Administration (FDA). This has led to a number of bills being introduced, the latest of which, the Drug Safety and Accountability Act of 2010 (linked by Pharmalot ), was put forward yesterday.
The bill would allow the FDA to recall drugs, grant it subpoena authority and give it the infrastructure needed to track global producers supplying the US. Biopharm firms would also be made to document each company involved in the manufacture of the product.
Michael Bennet, US Senator for Colorado, introduced the bill. A 400 per cent rise in drug recalls in 2009 and the globalisation of active pharmaceutical ingredient (API) production were cited by Bennet as reasons why the bill is necessary.
“It is time Washington took action to ensure the medicines Coloradans rely on are safe, and that those entrusted with the responsibility of developing these drugs are equipped to keep consumers out of harm’s way”, said Bennet.
Introduction of the bill has prompted responses from the industry. Brant Zell, of the Society of Chemical Manufacturers of America (SOCMA), said its members “strongly endorse” efforts to strengthen the FDA, adding that the Bennet legislation “is a good starting point”.
The Pharmaceutical Research and Manufacturers of America (PhRMA) was still to review the bill at the time of its statement in which it defended the industry and good manufacturing practices (GMP).
PhRMA said: “GMP requirements help to assure the safety, quality and purity of drug ingredients that are used in the US prescription drug supply. The US regulatory system for prescription drugs is the toughest and safest in the world.”
Little consumer confidence in Chinese drugs
Just six per cent of Americans are mostly confident about the quality of drugs manufactured in China, with 70 per cent saying they are not confident, according to a poll for the Pew Prescription Project.
India fared a little better, with eight per cent of respondents being mostly confident about drugs produced there and 54 per cent having no confidence.
The figures for China and India contrast with those for the US. Of those polled, 78 per cent said they are mostly confident about drugs manufactured in the US. Only four per cent of respondents said they are not confident about US drugs.
Of the other countries in the poll, 60 per cent of respondents are mostly confident about Canadian drugs, 47 per cent for Switzerland and 30 per cent for Ireland.