Thank you to Kenneth N. Woliner, M.D., A.B.F.M for the following information:
1. Previous post entitled The Thriving Compounding Pharmacy Industry In Tampa Bay is a press release. It was put out by Father David, LLC d/b/a "Maxcare Pharmacy" (http://ww2.doh.state.fl.us/
1. Previous post entitled The Thriving Compounding Pharmacy Industry In Tampa Bay is a press release. It was put out by Father David, LLC d/b/a "Maxcare Pharmacy" (http://ww2.doh.state.fl.us/
| FATHER DAVID, LLC | ||
| LICENSE NUMBER: PH25823 | Printer Friendly Version | |
2. The supervising pharmacist is Rita Shoukry, R.Ph. She has only had a license since October 6, 2011. Not exactly years and years of experience.
3. Dr. Scott Gottleib has nothing to do with this pharmacy. He might be surprised that they are using his name (and quotes from him, supposedly from a Forbes magazine article), as a way of promoting their pharmacy. Shouldn't he be "paid" for being a spokesman for this company? If I found out that a private company was using quotes from me in this manner, I would have my lawyer send them a "cease and desist" letter, telling them to stop, and to remunerate for the false use of my name.
4. Father David, LLC d/b/a MaxCare Pharmacy is actually owned by its supervising pharmacist. This is RARE IN FLORIDA. Florida is one a few states that doesn't prohibit unlicensed persons from owning medical clinics (such as the pain clinics that have been pumping out Oxycontin, Oxycodone, Xanax and Soma - creating addicts from Florida to Kentucky to Ohio ...; such as "Rejuvination Clinics" that pump out steroids (testosterone) and Human Growth Hormone (HGH) to Major League Baseball Players such as Alex Rodriguez and Ryan Braun; such as diet clinics that pump out HCG and Phentermine ... etc. http://search.sunbiz.org/
5. The reason why I bring up the "corporate practice of ____" (medicine, pharmacy, etc) - is that Florida is a hotbed for criminal activity because unlciensed businessmen (a.k.a. the mafia) will start these clinics and pharmacies as an easy way to do Medicare/Medicaid fraud, and/or prescribe/dispense drugs without medical justification. Florida is the laughing-stock of the country. 6. Regardless, this pharmacy wants to break into the compounding pharmacy business because it is so lucrative, and because regulation and enforcement is so lax. Hopefully, the U.S. Congress will not water down the Senate Bill going through the sausage-making machine. Hopefully, Florida's Legislature will pass stricter laws, but actually enforce the laws they have. I'm not as hopeful for Florida doing its part. We don't have a good track record, and there are so many probems I've uncovered at the Florida Department of Health's Bureau of Enforcement (that are not being addressed), that I feel that Florida will feed poisonous drugs to the nation for a long time to come (just look at Franck's Compounding Lab, Signature Pharmacy, etc.). | ||
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FLRITA ASHRAFSHOUKRY | ||
| LICENSE NUMBER: PS48469 | Printer Friendly Version | |
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Detail by Entity Name
Florida Limited Liability CompanyFATHER DAVID, LLC
Filing Information
L1100011963045364241310/19/2011FLAC
Principal Address
6512 U.S. HWY 19
NEW PORT RICHEY, FL 34652
NEW PORT RICHEY, FL 34652
Mailing Address
Changed: 06/11/2012
6512 U.S. HWY 19
NEW PORT RICHEY, FL 34652
NEW PORT RICHEY, FL 34652
Changed: 06/11/2012
Registered Agent Name & AddressAYOUB, LENA ESQ
1446 COURT STREET
CLEARWATER, FL 33756
CLEARWATER, FL 33756
Manager/Member DetailName & Address
Title MGRM
SHOUKRY, RITA A
Title MGRM
SHOUKRY, RITA A
7044 WOODIBIS DR
NEW PORT RICHEY, FL 34654
NEW PORT RICHEY, FL 34654
Annual Reports
| Report Year | Filed Date |
| 2012 | 06/11/2012 |
| 2013 | 04/24/2013 |
Document Images
| 04/24/2013 -- ANNUAL REPORT | View image in PDF format |
| 06/11/2012 -- ANNUAL REPORT | View image in PDF format |
| 10/19/2011 -- Florida Limited Liability | View image in PDF format
Here is that article by Scott Gottleib, MD.
 Pharma & Healthcare|5/24/2013 @ 8:59AM |7,788 viewsCompounding A Crisis At FDA
By Scott Gottlieb, M.D.
The tragic deaths of 55 Americans and sickening of more than 740, resulting from contaminated steroid injections that were shipped by a disreputable firm in Massachusetts, have focused public attention on a largely unfamiliar, but prominent part of our drug supply chain – the practice of pharmacy compounding.
Observers are calling on Congress to give FDA more power over these firms.
New laws merit consideration, and yesterday I participated in a hearing before the House Energy and Commerce Committee, Subcommittee on Health, as legislators consider how to shore up supervision of the drugs produced by these pharmacies. My testimony is available online.
Applying more vigilant rules to the compounding pharmacies starts with articulating clear and bright lines between the legitimate practice of pharmacy compounding (which should be subject solely to state and professional regulation and not FDA) and then those firms operating illegally as large-scale drug manufacturers under the guise of a pharmacy license. These firms should be treated as new drug makers, and subject to FDA oversight.
To these ends, FDA’s message, and how the agency is framing the problem, does not adequately explain the scope of the risks and its solutions.
The compounding industry has evolved rapidly over the past decade – in some cases, as a result of FDA’s own decisions that have given greater incentives to compounding firms to get into new, and sometimes-illegal markets.
For example, in recent years FDA has sometimes ignored compounders who were making cheap, but illegal (and unapproved) copies of FDA approved products. The FDA’s political chiefs had a preference for the cheap, compounded drugs. FDA has also largely allowed compounders to plug drug shortages that were created by FDA’s abrupt changes in how the agency oversees the sterile manufacturing operations at legitimate generic drug makers.
Now, FDA’s posture is that the agency doesn’t have enough authority to adequately regulate the burgeoning compounding industry.
Whether the broader problem was in part of FDA’s own making is partly material here. It speaks to the need for FDA to apply even enforcement in the future – and not cutting illegal drug makers some slack because the end products are cheap and thus politically popular. This is going to be especially true if FDA creates a new class of regulation for the compounding firms. Uneven enforcement could give these outfits unfair advantage to obviate the intellectual property of legitimate drug makers.
But all of this doesn’t change the fact that some “compounding” pharmacies are operating as drug makers under the guise of a pharmacy license, breaking existing law, and creating public risks. They are manufacturing drugs with none of the oversight that ensures that their processes are sterile and safe. FDA’s recent inspections of some of these facilities have surfaced widespread, and potentially dangerous biological contaminations of these products. Another tragedy is just a matter of time.
But FDA’s approach to framing the problem, and its preferred solutions, is not an easy sell. The problem is FDA’s pitch doesn’t match the purpose.
FDA has extensive authority to oversee the compounders that break the law. For the agency to say it “lacks authority” skirts important nuance.
Indeed, once a compounder starts operating as a drug manufacturer, FDA can regulate it. The problem is that the agency’s authority gives FDA tools that are cumbersome, hazy, and very hard to implement. And this is no small matter.
The result is that FDA is getting very little public health bang for the bucks that it spends on enforcement in this area, and it’s able to do little more than react to problems only after they become manifest (and people
are often harmed).
What FDA needs isn’t more authority, but authority that allows the agency to implement a workable regulatory regime based on legislative statute that is clear and efficient. In other words, this is a problem of lousy government regulation borne of a patchwork of fuzzy and disorganized statute.
It’s not an issue of too little authority. It’s an issue of outdated legislation that doesn’t match a modern industry and give FDA tools to anticipate problems, make sure large-scale drug manufacturing is done to modern sterility standards, and target regualtory resources based on the potential for risk.
No reasonably sized agency could erect an adequate regime under these rules. This is a chance for Congress to modernize regulation by writing good law.
Moreover, FDA’s existing rules — if fully enforced — would lead to binary outcomes that make it much harder for FDA to take action. If FDA suspects a firm has problems, it probably has to shut it down completely. FDA doesn’t have the oversight tools that allow it to remediate firms.
So in other words, FDA isn’t able to easily titrate its regulatory touch in this area to the level of risk that it finds. This makes it even harder for FDA to take action, since its regulatory steps have to be more draconian.
When the FDA Commissioner went before Congress some months ago, she was poorly received precisely because her message was so weak. Arguing that FDA doesn’t have authority to adequately regulate the compounders sounds like an excuse to absolve the agency of any complicity in the tragedy in Massachusetts. That doesn’t sell well in this environment. This isn’t to say that the deaths were somehow FDA’s fault. But hindsight being 20-20, there’s certainly more the agency could have done under its existing authority to crack down on bad firms like the one in Massachusetts.
The problem isn’t that FDA lacked the authority. The problem is that FDA has such a byzantine set of rules to operate from, that it has little capacity to match its resources to the vast scope of the industry that legitimately falls in its scope.
What FDA needs is a more efficient approach to regulating firms that fall under its purview. That starts with a more efficient set of rules in legislation.
It also starts with FDA making an explicit admission about those local compounding pharmacies that it doesn’t regulate – the ones that belong squarely under state and professional oversight. Next, it means laying out a clear set of criteria when these firms cross the line into being drug manufacturers, and fall under the FDA’s thumb.
You can follow Dr. Scott Gottlieb on Twitter @ScottGottliebMD
A recording of the hearing can be found at the Committee Website.
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