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| Michael Bennet, courtesy of politico.com |
On August 3rd, 2010, Senator Michael Bennet, a Democrat from Colorado, introduced a new piece of legislation - the Drug Safety and Accountability Act of 2010. The Act aims to put in place the steps needed to ensure the safety of the U.S. drug supply. The bill would grant the Food and Drug Administration (FDA) more authority regarding drug safety, and at the same time increase the accountability that drug companies own over the drugs that they manufacture and sell to the public.
The introduction of this Act comes at the same time as the release of a survey commissioned by the Pew Prescription Project and conducted by Public Opinion Strategies and Hart Research Associates. The poll included interviews from approximately 800 likely voters in 2010, which were sampled demographically to represent the national electorate. The results showed that Americans strongly endorse individual regulatory measures. For example, 85% strongly favored that manufacturers must inform the FDA when they find contamination. Similarly, 82% strongly favored the FDA having the power to issue mandatory drug recalls. Overall, nearly 9 in 10 Americans supported new measures be put in place to ensure drug safety.
Senator Bennet’s bill would improve upon the system the FDA uses to track international manufacturers providing ingredients and drugs to the U.S., thereby giving the drug companies better oversight of their contractors. However, one of the most significant authorities the bill would grant would be to empower the FDA to mandate drug recalls when safety issues arise.
What do you think? What are your attitudes towards prescription drug safety in the U.S.? Is the system working well the way it exists now, or do we need stronger safety measures?
The introduction of this Act comes at the same time as the release of a survey commissioned by the Pew Prescription Project and conducted by Public Opinion Strategies and Hart Research Associates. The poll included interviews from approximately 800 likely voters in 2010, which were sampled demographically to represent the national electorate. The results showed that Americans strongly endorse individual regulatory measures. For example, 85% strongly favored that manufacturers must inform the FDA when they find contamination. Similarly, 82% strongly favored the FDA having the power to issue mandatory drug recalls. Overall, nearly 9 in 10 Americans supported new measures be put in place to ensure drug safety.
Senator Bennet’s bill would improve upon the system the FDA uses to track international manufacturers providing ingredients and drugs to the U.S., thereby giving the drug companies better oversight of their contractors. However, one of the most significant authorities the bill would grant would be to empower the FDA to mandate drug recalls when safety issues arise.
What do you think? What are your attitudes towards prescription drug safety in the U.S.? Is the system working well the way it exists now, or do we need stronger safety measures?
I think the oversight would be good, and the new Act has the best of intentions, but the current FDA could not provide the oversight at the level that is desired by people right now. They'd need significantly greater funding and a larger staff. The FDA just doesn't have the human personnel at this time to put any teeth behind this Act.
ReplyDeleteI'm not sure, but is this Accountability Act the Legislature which mandated that companies have to perform on-site inspections of contractors now, not just questionairres? That's another good step but I also think this adds more costs to the drug consumer (Patient) as Pharma companies have to add more staff or pay more money to 3rd party agencies to perform these inspections for them. It all ends up costing the taxpayer and patient more money, but a higher level of drug product quality is the result.