FDA Regulatory Policy Can Work

[McGyver]

After spending more than an hour in reply to what appeared to be an abandoned thread on the FDA, I felt my discussion so important as to post it as a NEW thread. Forum moderator please advise if I took the best approach. I have some extraordinary experiences with the CDRH (Center for Devices and Radiological Health) division of the FDA as a patient, patient advocate, and a scientist and inventor. The CDRH division regulates medical devices, everything from bandaids, to CNS shunts, to imaging scanners. The FDA just began regulating products in 1976, and most all existing products were grandfathered in with the 1976 FDA Act, the implications of which is a whole other discussion. I received a CNS Delta shunt implant to treat hydrocephalus following a 1992 auto accident. I was familiar with FDA regulations from prior medical work. But when it appeared that my "poor" post surgical outcome could be due to critical reports on this Delta shunt (Medtronic/PS Medical), it was safer for the U.S. neurosurgery field to just abandon me as a patient. I was then forced to explore and confirm this via a 1996 FDA Petiton, to which the manufacturer failed to report for years. I actually had to invent a new CNS Shunt Testing system, the DiaCeph Test, in order to get corrective surgery. After the FDA concurred with my Petition, they cut me off and refused to allow me to speak at the very 1999 STAMP Conference I helped create. Our U.S. health system is the most advanced and lucrative in the world, and with that comes responsibility. The most critical oversight mechanism is the "reporting" requirement, that is, when manufacturers become aware of problems with a drug or medical device through ANY means, that they are required to report this to the FDA within (I believe) 30 days. If they fail to do so, they can face stiff fines and JAIL. In the case of the CNS Delta shunt, the FDA kept their findings out of public record so that Medtronic could escape criminal prosecution, and could successfully acquire Sofomar Danek in the Oct. 1998. What may have been good for Wall Street handicapped an industry, when without accountability, Medtronic/PS Medical was able to take over as the market leader in the CNS shunt products industry. The reporting requirement works on the HONOR system, and SHOULD encourage more open dialogue between FDA and mfrs. But it hasn't. Instead, we've gotten extreme positions on either side of science. Issues are expected to arise in the approval process, but mfr's should refrain from using lobbyist to exert influence and interefere with FDA protocols, as this compromises science and integrity. Rather, they should use open communication, leading science, and reasonable compromise. Making things worse, some FDA scientists have left FDA posts and taken positions with the very companies who's products they were approving. Simply the appearance of impropriety is enough to raise suspicion with so much at stake, and so much behind public view. No drug or medical device will ever be 100% free from issues or defects under every condition. It is up to industry to continually re-evaluate and improve QA practices, and take us into the 21st Century. With more open lines of communication of issues of oversight, and product science and use, we just might find a healthy workable middleground. You can read much more on my efforts and experiences with CNS shunts and FDA modernization at http://www.diaceph.com/hydrocephalus.htm.

[Biochemist]

After spending more than an hour in reply to what appeared to be an abandoned thread on the FDA, I felt my discussion so important as to post it as a NEW thread. Forum moderator please advise if I took the best approach. I have some extraordinary experiences with the CDRH (Center for Devices and Radiological Health) division of the FDA as a patient, patient advocate, and a scientist and inventor.

I am not sure if a thread is ever really abandoned here. I am sure that Tormod (our forum kingpin) wishes that some were.

 

I found your note on the old thread, but it probably makes sense to carry on the discussion here. Talk to me a little but about how the approval process for medical devices is different than the process for drugs.

[C1ay]

I am not sure if a thread is ever really abandoned here. I am sure that Tormod (our forum kingpin) wishes that some were.

You will find threads inactive by a month or more locked in the Astronomy/Cosmology and Physics/Math forums. This forces fresh new threads with the active member population instead of new members bringing old discussions back to the top by quoting members that may not be currently active.

[McGyver]

The FDA just began regulating products in 1976, and most all existing products were grandfathered in with the 1976 FDA Act, the implications of which is a whole other discussion.

The most significant handycap with the Federal Food and Cosmetic Act of 1976 (FDA's inception) is that it deters mfr's from pioneering NEW drugs and devices by requiring an exhaustive 7 year plus PMA submission and clinical trials, whereas, if a mfr just "tweaks" existing drugs or device technology a wee bit - they can file a 510k with the FDA and be marketing their product in as little as 6 months. Huge disparity in the costs, protocols, and time. Plus, mfr's are required to follow outdated NIH clinical trials protocols, which were contributing factors in many of the U.S. drug safety revellations in recent years. The FDA new product submission processes must be revamped.

[Biochemist]

The FDA new product submission processes must be revamped.

How would you suggest the procedures be revamped to decrease time-to-market (and the incridibly cost associated with the delay) yet still maintain adequate safety?

[McGyver]

How would you suggest the procedures be revamped to decrease time-to-market (and the incridibly cost associated with the delay) yet still maintain adequate safety?

I have written recommendations in FDA papers on this topic in the past. My first concern is the too simplistic requirements of the 510k process, that is, mfr's are only required to issue literature and user instructions in line with the ORI product submission - which can be many years old. There are dis-incentives and possible penalties for mfr's who might want to to be explorative with existing technology. Look at how the consumer sector operates. More info, features etc. is better. But in FDA products, this approach presents obstacles NOT worth the venture. The same holds true when co's want to add new marketing claims. The reality is that a great percentage of FDA regulated products are being used in "off label" applications, that is, MD's can prescribe them but mfr's can't claims or write about them. It's llike "Don't Ask, Don't Tell." There are hundreds of examples. Also, off label uses sometimes lead to no insurance reimbursement - a whole other cost/efficacy issue. Secondly, I would allow mfr's and industry sectors to modify NIH clinical study protocols to better represent the pros and cons ofr their products. This would also allow a better free flow of favorable and adverse data discovered during clinical trials, where FDA and mfr's can address and hopefully rectify right then without protrated extensions and cost. There needs to be more incentive for mfr's to disclose adverse data during trials, rather than have surprise safety issues arise after the products are on the market. Thirdly, the FDA needs to have subdivisions of the PMA filing requirements based upon needs, risks, anticipated future alternate treatments. Clearly, drugs pose different types of and often more problematic risks to patients than do medical devices. The trial courts are an adjunct to the FDA's efforts in market oversight. Again, a whole other discussion. You can read many of my efforts for CNS shunts at http://www.diaceph.com/RegulatoryAffairsandLaw.htm. Stephen Dolle.

[Biochemist]

The reality is that a great percentage of FDA regulated products are being used in "off label" applications...Also, off label uses sometimes lead to no insurance reimbursement

I believe that non coverage for off-label use is rare, unless the drug was excluded from formulary for its "on label" usage.

I would allow mfr's and industry sectors to modify NIH clinical study protocols to better represent the pros and cons ofr their products. This would also allow a better free flow of favorable and adverse data discovered during clinical trials...

How would you alter the standards to the the mfr's to be more open? My experience with these firms is that they are remarkably proprietary, and they will go to great lengths to avoud disclosure of anything, out of fear of competition. My experience is that they are not afraid of disclosing safety issues- just relasing competitive informaiton.

[McGyver]

I believe that non coverage for off-label use is rare, unless the drug was excluded from formulary for its "on label" usage. How would you alter the standards to the the mfr's to be more open? My experience with these firms is taht they are remarkably propritary, and they will go to great lengths to avoud disclosure of anything, out of fear of competition. My experience is that they are not afraid of disclosing safety issues- just relasing competitive informaiton.

I'll try to answer above briefly, but you are asking for information that is a key component to my consulting and communications services. With respect to insurance reimbursement, the saying holds true that if a mfr can't get reimbursement, don't bother to submit to FDA + bring to market. HICFA committees still are the primary determinent of what gets reimbursed, and there remains a great deal of pressures from many org's and political causes to get coverage. Fir initial FDA marketing approval, mfr's are concerned with reimbursement. But not for subsequent applications where no further FDA marketing claims are sought. It's purely a fiscal business decision. Physicians are ordering and prescribing a lot more off label uses than you might imagine, because they can do it the instant new info and studies are made known, whereas, you're looking at another 1-3 years and costs for new marketring claims and subsequent reimbursement. Private insurance, though they state "officially" their policies cover items prescribed by a physician, in reality they often do not. Instead they look to HICFA and FDA decisions. An entire secondary issue here is medical testing and procedures initially submitted for certain disoders, but where subsequent discoveries of efficacy become available - and insurance will not cover. AIDS and other org's took to the streets for access to. More recently, it was women with metasticising breast cancer being denied PET imaging and bone marrow transplant therapy. If we could better expedite our U.S. reimbursance beaurocracy alone, we'd save money, lives, and benefit in more efficacious care. As to any further responses on the above discussions, I'll leave that to my Dolle Communications and consulting business at http://www.diaceph.com. Stephen Dolle.