tag:blogger.com,1999:blog-16774010.post2014463617629962732..comments2024-01-25T17:58:34.297-05:00Comments on Scott's Web Log: FDA Indicates Biotech Knockoffs Might Have Different Status Than "Generics"Scott Shttp://www.blogger.com/profile/03286529314567223617noreply@blogger.comBlogger4125tag:blogger.com,1999:blog-16774010.post-52969600930573417872007-03-17T12:56:00.000-04:002007-03-17T12:56:00.000-04:00Although I'm not completely certain, I believe mos...Although I'm not completely certain, I believe most of the public hearings on this subject were done in 2005 (a quick search of the FDA's website shows testimony, presentations and other documents from BIO, GPhA, not to mention companies including Pfizer, Teva, Barr Pharmaceuticals and others).<BR/><BR/>While the FDA arguably has everything they need to move on the issue, the Agency's leadership has been unwilling to move on the issue, instead saying that Congress needs to pass laws to move ahead on the issue. The pharmaceutical industry was among the biggest contributors to major Republican Congressional candidates, and the underlying assumption was that they did not need to fear any legislation that would threaten their perpetual monopolies.<BR/><BR/>But then came Congressional passage of the Medicare Prescription Drug Benefit which meant the Federal government suddenly had to pay for all these drugs, followed by the Jack Abramoff lobbyist scandal, capped by last year's Democratic victories, and suddenly, the issue is on the table again.<BR/><BR/>I'm not sure how much more public input will be asked for on the issue, but I suspect if passed, the FDA will have some work to do on this issue and could seek more input. I'll see if I can find any names, in the interim, I would suggest contacting your Congressional representatives to express your support for the bill and above all, tell them why. They tend to react much better when there is a personal story attached!Scott Shttps://www.blogger.com/profile/03286529314567223617noreply@blogger.comtag:blogger.com,1999:blog-16774010.post-29570483643132210902007-03-17T00:12:00.000-04:002007-03-17T00:12:00.000-04:00ScottThanks for keeping me so informed on this slo...Scott<BR/><BR/>Thanks for keeping me so informed on this slow process.<BR/><BR/>Sometimes the speed at which the FDA moves just infuriates me.<BR/><BR/>I'm curious. Have you found some within the FDA who can be contacted for more information? Is there any public meeting about this in the future?<BR/><BR/>I testified in front of the FDA when they were having the approval meeting for Humalog. And I think I'd be interested in doing again if it happened for something like the issue you're researching.<BR/><BR/>What really helped me at that time was establishing a contact within the FDA. That was many years ago, otherwise I might still have that name.Bernardhttps://www.blogger.com/profile/14936264471078732019noreply@blogger.comtag:blogger.com,1999:blog-16774010.post-8085910400469945302007-03-16T14:14:00.000-04:002007-03-16T14:14:00.000-04:00But by not referring to them as equivalent, the FD...But by not referring to them as equivalent, the FDA is acknowledging that these would not be exactly the same. Today, managed care does something similar in that they have "preferred" medicines, while nonpreferred meds may carry a different price tag. They are not calling them bioequivalent, which is an acknowledgement that they cannot call them interchangable.Scott Shttps://www.blogger.com/profile/03286529314567223617noreply@blogger.comtag:blogger.com,1999:blog-16774010.post-52565997353646097752007-03-16T14:02:00.000-04:002007-03-16T14:02:00.000-04:00By flooding Generics unto the Marketplace, Insuran...By flooding Generics unto the Marketplace, Insurance Agencies as well as Medicare will eventual force people to use "their recommended products" rather than give freedom of choice as regards the purchase and availability of needed medications. This is always what occurs when there is too much Government involvement with anything. It is not always to the patient's benefit, but more with the bottom line, how much $$ can we save which again is not always in the patient's best interest. I want Freedom of Choice. Unfortunately, very few people know that there is a difference in quality control and bioavailability regarding Generics and Brand Name Pharmaceuticals.BetterCellhttps://www.blogger.com/profile/13667917240368089110noreply@blogger.com