Newsletter - August 20, 2015
Celebrity Endorsement and FDA: An Unwinnable Battle for the Agency
Kim Kardashian tweets about a morning sickness drug and the world goes crazy. By this time, if you have not heard about it, you may be the only one in the world. But this is not the first time celebrity endorsements have been used by companies to make misleading claims. Celebrities are used to sell all kinds of consumer goods so why not drugs. And FDA does not prohibit using key figures to endorse a given drug product; we have seen Phil Mickelson’s Embrel campaign, Bob Dole’s Viagra campaign, and many other famous people endorsing drugs with no issues from FDA. But when these ads are used to mislead and deceive, they become an issue. Read More...
Female Viagra Marketing Set to Test Off-Label Sale Rules Post FDA Approval
On 18th August FDA finally approved Addyi (flibanserin) popularly known as the “Female Viagra”. Third time was the charm for the manufacturer, Sprout Pharma, who learnt from there previous two failures and gamed the Advisory Committee using aggressive campaign to claim that their product should be approved despite all the safety concerns and marginal effectiveness because there was no other treatment for loss of female libido. It doesn’t matter that the drug is not specific to loss of libido and that it’s mechanism of action is not known. FDA had a no win situation where it would have been criticized no matter if it decided to approve or not, and hence it took the safer route of approving the drug with severe limitations. Read More...
Office of Generic Drugs Opens the Door a Bit to Get Timely ANDA Updates
FDA released a new internal policy on 17th Aug whereby sponsors of ANDA applications will soon start receiving timely updates regarding the status of their application’s review. Under this new policy the Regulatory Project Managers (RPMs) at Office of Generic Drugs (OGD) will respond to any status inquiries from authorized representatives of the companies within 2 business days. By moving the responsibility of responding to queries to RPMs instead of reviewers, team leaders, discipline project managers, division directors, deputy division directors, other CDER management, or any other CDER staff, FDA intends to make the process more efficient. Read More...
Celebrity Endorsement and FDA: An Unwinnable Battle for the Agency
Kim Kardashian tweets about a morning sickness drug and the world goes crazy. By this time, if you have not heard about it, you may be the only one in the world. But this is not the first time celebrity endorsements have been used by companies to make misleading claims. Celebrities are used to sell all kinds of consumer goods so why not drugs. And FDA does not prohibit using key figures to endorse a given drug product; we have seen Phil Mickelson’s Embrel campaign, Bob Dole’s Viagra campaign, and many other famous people endorsing drugs with no issues from FDA. But when these ads are used to mislead and deceive, they become an issue. Read More...
Female Viagra Marketing Set to Test Off-Label Sale Rules Post FDA Approval
On 18th August FDA finally approved Addyi (flibanserin) popularly known as the “Female Viagra”. Third time was the charm for the manufacturer, Sprout Pharma, who learnt from there previous two failures and gamed the Advisory Committee using aggressive campaign to claim that their product should be approved despite all the safety concerns and marginal effectiveness because there was no other treatment for loss of female libido. It doesn’t matter that the drug is not specific to loss of libido and that it’s mechanism of action is not known. FDA had a no win situation where it would have been criticized no matter if it decided to approve or not, and hence it took the safer route of approving the drug with severe limitations. Read More...
Office of Generic Drugs Opens the Door a Bit to Get Timely ANDA Updates
FDA released a new internal policy on 17th Aug whereby sponsors of ANDA applications will soon start receiving timely updates regarding the status of their application’s review. Under this new policy the Regulatory Project Managers (RPMs) at Office of Generic Drugs (OGD) will respond to any status inquiries from authorized representatives of the companies within 2 business days. By moving the responsibility of responding to queries to RPMs instead of reviewers, team leaders, discipline project managers, division directors, deputy division directors, other CDER management, or any other CDER staff, FDA intends to make the process more efficient. Read More...
