Sunday, September 29, 2013

A different view of animal health: Holistic veterinarians are growing in number, acceptance

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Question of Day September 29, 2013 Does federal compounding legislation contain sweeping and unprecedented authority in determine what pharmacies can compound? What happen to provision of committee made up of experts?




Congress, FDA playing blame game on outbreak Year of finger-pointing lingers between Congress and FDA; legislation introduced


Written by
Christopher Behnan
Daily Press & Argus

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House passes Drug Quality and Security Act; Senate passage is likely September 29, 2013


Bill includes voluntary oversight by FDA of outsourced compounded pharmaceuticals, national distributor licensure, and a timetable for serialization and drug tracking
 
Pharma track-and-trace, and tighter regulation of compounding pharmacies, is almost here.
 
In the middle of a high-tension day (Sept. 28) when the House spent hours debating the funding of the Affordable Health Care Act—and the government itself—the legislators paused to approve (by voice vote, indicating a non-controversial action) HR 3204, the Drug Quality and Safety Act. Earlier in the week, both Rep. Fred Upton’s (R-MI) Energy and Commerce Committee and Sen. Tom Harkin’s (D-IA) HELP Committee issued press releases acclaiming a bicameral, bipartisan breakthrough in getting House and Senate versions of the law unified. Sen. Harkin issued a statement applauding the passage, and urging full consideration by the Senate. 
 
In retrospect, the Senate took a gamble, earlier this year, in combining bills addressing supply chain security and compounding pharmacy regulation. The former has been tossed back and forth for years (the so-called pedigree rules for tracking drugs go all the way back to the Prescription Drug Marketing Act of 1987, passed during the Reagan Administration), while the latter rose to public attention in the aftermath of the NECC compounding scandal, from last year, which has killed, at current count, 64 patients and sickened hundreds more. The House had passed a supply-chain security bill only (HR 1919) last spring, and subsequent hearings about including drug compounding had mixed reactions. But the gamble worked, and insofar as press statements are concerned, the compounding legislation carried the supply-chain legislation through to passage.

Continue to read here
 
The key decisions in HR 3204 for compounding:
  • Voluntary federal registration as an “outsourcing facility” for compounding. The bill does not define how such a facility differs from the corner pharmacist (unregistered for the purposes of this law) who might be compounding individual doses for customers.
  • Beginning in FY 2015, a registration fee of $15,000, and an additional $15,000 (inflation-adjusted) for inspections will be assessed on outsourcing facilities.
  • A list will be developed of drugs for which compounding at an outsourcing facility is to be avoided.
  • Compounded drugs from outsourced facilities will have a label saying “this is a compounded drug” or equivalent language.
  • Enhanced communication is to occur between state boards of pharmacy and FDA for warnings or other compliance issues at outsourcing facilities.
Title II of the bill covers supply chain security:
  • Manufacturers, wholesale distributors, repackagers and third-party logistics providers (a first for the latter) will have a federal registration process to undergo

key dates related to meningitis court break


Nov. 21, 1997: The federal Food and Drug Administration Modernization Act, enacted by Congress and signed by President Bill Clinton, takes effect, exempting compounding pharmacies from FDA drug approvals but prohibits those companies from advertising their products.
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Voluntary registration to commit murder? Compounding drug pharmacies win, we lose| Jason Gooljar | WFPman

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State senator/physician gets attention for injections, vote on compounding bill

A member of the Tennessee Senate was one of the doctors who injected patients with a spinal steroid at a Nashville outpatient clinic in the months immediately preceding a national fungal meningitis outbreak that took the lives of 16 Tennesseans.  Continue to read here

I have to totally agree with these comments--bill will do nothing to prevent another NECC/Franck's/Apothercure

I don't know where we're going, but we're making great time." This train has left the station. The Senate will voice vote their approval of the bill without changes, and with all this "sequester talk" due to Obamacare battles, the President will not expend political capital by vetoing this bill. The "voluntary" provision makes it likely rogue compounders won't register. The lack of enforcement due to state Departments of Health dropping the ball (not doing appropriate inspections; not investigating legally sufficient complaints; not prosecuting cases that are related to split-fee/kickback relationships with prescribers; etc), makes this bill (soon to be law) have no chance of stopping another NECC / Franck's / ApotheCure type tragedy with patients (human and veterinary) being blinded, maimed, and dying en mass. As long as the regulatory agencies (FDA, State Boards of Pharmacy and the investigators/prosecutors in their Bureaus of Enforcement) "use their gums, not their teeth", patients will not be protected. on update from iacp-bill goes back to senate next week

comments from Dr. Kenneth Woliner

Saturday, September 28, 2013

Pew Applauds House Passage of Landmark Legislation to Enhance Drug Safety


* Reuters is not responsible for the content in this press release.

Sat Sep 28, 2013 4:43pm EDT

Pew Applauds House Passage of Landmark Legislation to Enhance Drug Safety

PR Newswire
The Pew Charitable Trusts thanks congressional leadership for advancing patient safety by moving forward with legislation to implement a "track and trace" system to authenticate medicines through the U.S. pharmaceutical supply chain and enhanced federal oversight of pharmaceutical compounding. The Drug Quality and Security Act (H.R. 3204) is a tremendous victory in the bipartisan effort to improve oversight and strengthen the quality and safety of drugs in the United States. The legislation passed the U.S. HouseSeptember 28 and now moves to the Senate, where supporters anticipate approval.  
Allan Coukell, senior director of drugs and medical devices at The Pew Charitable Trusts, said bipartisan support in both the House and the Senate was strong, and thanks several lawmakers as champions for the bill: Senate Committee on Health, Education, Labor and Pensions chairman Tom Harkin (D-IA) and ranking member Lamar Alexander  (R-TN), House Energy and Commerce Committee chairman Fred Upton (R-MI), ranking member Henry Waxman (D-CA), Health Subcommittee Chairman Joe Pitts (R-PA) and ranking member  Frank Pallone (D-NJ).
"At a time when it often seems difficult for Congress to achieve bipartisan progress, this victory stands out as a genuine accomplishment. Too many people have died or suffered terrible illness and injury when counterfeit drugs or other unsafe medicines have been introduced into the drug supply chain, and the House has taken strong action to meet that challenge.  We urge the Senate to pass it as quickly as possible and send it to the President for his signature," said Coukell. "This landmark legislation will establish a long-awaited national system to electronically track the drugs distributed in this country and represents a major improvement in protecting patients and safeguarding our drug supply."
Title II, Drug Supply Chain Security, would establish a national standard of tracing requirements from manufacturers to wholesale distributors to pharmacies to patients. The provision has received broad support from patient and industry groups that helped shape it over the past two years. Coukell said bipartisan support for these provisions was particularly strong, and he singled out four additional lawmakers for their work:  Sens. Michael Bennet (D-CO) and Richard Burr (R-NC), and Reps. Bob Latta (R-OH) and Jim Matheson (D-UT).   

Huffington Post Has some very interesting comments from readers regarding the House passing the compounding legislation bill

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