Prescription Drug User Fee Act-Drug Approval Process-Medical Device-Congress-FDA

Bipartisanship in Congress, in Support of Pharma and Device Industries

It's often said today that Congress is totally dysfunctional and cannot agree on anything due to the huge partisan culture war. Well, the good news is that there's bipartisan cooperation on at least one issue. The bad news is that it's all in favor of handing the foxes at the pharmaceutical and medical device industries the key to the FDA henhouse. 
The estimable Merrill Goozner: http://gooznews.com/?p=3914--has blogged about the latest renewal round of the Prescription Drug User Fee Act, where drug firms agree to pay a lot of the freight for running the FDA's drug approval process, and almost always manage to wring out favorable concessions in exchange for their largesse. Among the Christmas list the industry wants this time, and that Congress, well primed by the lobbyists, is apparently ready to hand them, are:

• More use of surrogate markers to approve new drugs, without demanding proof that the actual diseases that affect people get any better (e.g., a drug that lowers blood sugar but does nothing to prevent heart attacks or strokes or blindness from diabetes)
• Complete gutting of the reforms called for in the recent Institute of Medicine report to toughen requirements for testing new devices for safety

Gooz reports that consumer advocacy groups are incensed over these concessions but are getting nowhere with Congress.
The solution, as we have known for a good while, is to stop depending on the drug industry to fund the FDA--though replacing drug bucks with taxpayer bucks won't make that army of lobbyists go away (meaning that at some point or other, campaign finance reform is desperately needed as well). read more..

Medical Device Marketing-Marketing Campaign-Consumer Reports-Medical Research-Medical Devices

Medical Device Marketing Don't Need No Stinkin' ROI!

"Standards for devices exist, they just don't make sense," industry critic Dr. Diana Zuckerman, president of the National Research Center for Women & Families, said in a Consumer Reports release (also read this CBS report "Investigation: Most medical devices implanted in patients without testing"; see video below).
"An investigation by Consumer Reports, which included interviews with doctors and patients and an analysis of medical research and a device-safety database maintained by the FDA, shows the following areas of concern:

• Medical devices often aren’t tested before they come on the market. “What they’re doing is conducting clinical trials on the American public,” says Dan Walter, a political consultant from Maryland. His wife was left with heart and cognitive damage from a specialty catheter, cleared without testing, that malfunctioned during a procedure to treat an abnormal heartbeat.
• There’s no systematic way for the government, researchers, or patients to spot or learn about problems with devices. “A coffeemaker or toaster oven has a unique serial number so if a problem is found, the company can contact you to warn you. Your artificial hip or heart valve doesn’t,” Zuckerman says. “Your doctor is supposed to notify you of a problem but may not be able to if he has retired or passed away.”
• Without major changes in the system, there’s not much that patients can do to protect themselves.

According to Consumer Reports, the majority of medical implants are not tested to make sure they are safe. Most of the time device manufacturers only need to pay the Food and Drug Administration (FDA) a fee of about $4,000 with minimal testing in order to get approval for marketing. Compared to drug approval, this is a walk in the park.
In fact, sometimes device manufacturers bypass this minimal approval process altogether as did Johnson and Johnson's Ethicon unit (see "J&J Marketed Medical Device Without FDA Approval").
Not only is the approval of medical devices by FDA more lax than the process used to approve drugs, medical device marketing is worlds apart from Rx drug marketing as I learned from a presentation made by a Medtronic marketing VP. The presentation focused on a case study of a marketing campaign for the Prestige Cervical Disc.
That case study showed that out of an estimated 5 million spine surgery candidates (patients) in the US, Medtronic only needed to capture 125 of them to break even on a very successful marketing campaign that reached 6.2 million local TV viewers, 80.5 million radio (especially satellite radio) listeners, 4 million print readers, and 73 million Internet browsers. (Get more details about that case study by downloading this Pharma Marketing News article: "Medical Device Marketing: Worlds Apart from Rx Drug Marketing"; use discount code 'DEV444' BEFORE April 15, 2012 to get it FREE!).
While drug advertisers would sweat and moan over whether such a campaign would have a positive ROI (return on investment), medical device marketersdon't need to worry about no stinkin' ROI because of such low numbers of conversions required AND also because very little resources need to go into premarket testing in order to get FDA approval. read more..