Supreme Court: Does FDA approval mean drug companies are immune from prosecution?
Feb/26/2008 06:00 Filed in: Regulatory
Environment
There
are always risks in taking prescription drugs,
especially over the long term, but then that is what
fair balance is supposed to be about. The real risks,
as demonstrated over the last few years, with
prescription drugs is pharma companies manipulations
or withholding data from the public. So the issue
becomes one of trust: how much would we, the public,
trust pharma companies to disclose data from ongoing
clinical trials if the data is unfavorable ? One only
has to look at Lilly's Zyprexa and the correlation of
people using the product and weight gain and diabetes
or the latest Enhance trials for Vytorin to get a
picture of the possibilities. And if there was data
that reflected on a product unfavorably how would
people get access to this data or knew it even
existed?
This BLOGGER has before in posts recommended that the all new drugs that are approved carry an additional warning such as the following:
How hard is that? People can go online to see if there are new warnings or precautions and even register so that drug companies can be proactive in informing their customers about product risks and benefits. This is the kind of customer centered strategy that most drug companies don't want to follow because it's about new Rx's not existing customers.
Litigation against pharmaceutical products has gotten out of hand and benefitted trial lawyers not patients. If there is proof that any pharma company withheld data that could effect sales then they deserve to write checks with a lot of zero's but some cases make no sense at all as demonstrated by the Vioxx litigation in which no correlation can be shown between a heart attack and Vioxx. What is so amazing here is that with all the news, mostly bad, about prescription drugs the Supreme Court would be hearing this case now.
This BLOGGER has before in posts recommended that the all new drugs that are approved carry an additional warning such as the following:
"This drug was approved by the FDA in February of 2008. While the maker has conducted clinical trials to ensure that this product is safe and efficacious ongoing clinical trials are still being conducted which may lead to some new side effects. To see of list of these possible new side effects go to www.product.com/ongoing and to receive updates about this product please register at www.product/com/register as a patient.
How hard is that? People can go online to see if there are new warnings or precautions and even register so that drug companies can be proactive in informing their customers about product risks and benefits. This is the kind of customer centered strategy that most drug companies don't want to follow because it's about new Rx's not existing customers.
Litigation against pharmaceutical products has gotten out of hand and benefitted trial lawyers not patients. If there is proof that any pharma company withheld data that could effect sales then they deserve to write checks with a lot of zero's but some cases make no sense at all as demonstrated by the Vioxx litigation in which no correlation can be shown between a heart attack and Vioxx. What is so amazing here is that with all the news, mostly bad, about prescription drugs the Supreme Court would be hearing this case now.
|