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

Read here

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.

Continue to read

Voluntary registration to commit murder? Compounding drug pharmacies win, we lose| Jason Gooljar | WFPman

Read here

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

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

Sept. 28

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

read here

September 28, 2013 From Sentencing Law and Policy--Could execution drug difficulties and switches result in real public health problems? , headlined "Use of drug for execution might cut supply: Missouri plans on using common anesthetic in October to kill convicted murderer."

The question in the title of this post is prompted by this AP article, headlined "Use of drug for execution might cut supply: Missouri plans on using common anesthetic in October to kill convicted murderer." Here are excerpts:

The planned use of a common anesthetic in a Missouri execution is raising concerns that the anti-death penalty European Union could limit export of the drug, endangering the supply of a vital medication used every day in thousands of American hospitals and clinics.

The execution scheduled for Oct. 23 would be the first to use propofol, which is by far the nation’s most popular anesthetic. About 50 million vials are administered annually in some 15,000 locations.  That’s about four-fifths of all anesthetic procedures, according to the American Society of Anesthesiologists.  Propofol is popular because it works quickly and patients wake up faster with fewer side effects such as post-operative nausea.

Roughly 85 percent of the U.S. supply of propofol is made in Europe, where capital punishment is outlawed, by the German company Fresenius Kabi.  Export is controlled by the European Union, which prohibits trade in goods that could be used for executions.  The EU is reviewing whether to subject propofol to that rule.

If it is added to the regulation, propofol would be subject to export controls, not a complete ban, EU spokeswoman Maja Kocijancic said. Still, any change in export practices could have a drastic effect on propofol’s availability in the U.S., said Matt Kuhn, a spokesman for Fresenius Kabi USA. “It’s a real concern,” Kuhn said Friday. “And it could have enormous public health implications.”

Fresenius Kabi has launched a website specifically to address the ramifications of using propofol in a U.S. execution, http://propofol-info.com. The Food and Drug Administration is worried about any move that could affect access to propofol. FDA spokeswoman Erica Jefferson said the agency is weighing how to reach out to European officials to ensure the drug remains readily available. “We do consider this a critical need,” Jefferson said. “Without the drug, we’re concerned that surgeries would be delayed and patients would be at risk.”

Until recently, Missouri and other states with the death penalty used virtually the same three-drug protocol. That changed in recent years as drug makers stopped selling the traditional execution drugs to prison officials because they didn’t want them used for lethal injections.

Last year, the Missouri Department of Corrections turned to propofol, which made headlines in 2009 when pop star Michael Jackson died after overdosing on the drug. So far, Missouri is the only state to adopt propofol for executions, though it has not yet put anyone to death with the drug.

At one point, the shortage of execution drugs was so concerning in the state that Attorney General Chris Koster hinted that use of the gas chamber was a possible alternative. Missouri used gas for executions in the early 1900s but no longer has a working chamber.

PCCA responds to the new “Drug Quality and Security Act”--They Decided o Be Neutral!

SEPTEMBER 28, 2013 BY PROTECT MY COMPOUNDS

September 27, 2013

A bipartisan, bicameral agreement on compounding has been linked to the track-and-trace bill, known as the “Drug Quality and Security Act” (HR 3204). Leaders from the House Energy & Commerce Committee and Senate Health, Education, Labor & Pensions Committee made the announcement September 25, and released bill language late that night. Revisions to the bill were made the following day. Proponents in the House are trying to pass the bill under “suspension of the rules”, meaning they need two-thirds of the House to support the track and trace/compounding compromise.  We expect this could happen as soon as tomorrow, Saturday September 28.

In conversations with key legislators, PCCA was able to get clarification in the bill which allows compounding pharmacies to elect to become “outsourcing facilities” on a voluntary basis. This is an important change as the first draft of the bill was ambiguous on this point. With the voluntary election provision, the bill paints a clear picture as to why a pharmacy may elect to become an outsourcing facility and, more importantly, shows that the FDA cannot force a pharmacy to become an outsourcing facility because of some arbitrary rule the FDA would feel it could enforce.

There are some additional improvements made to this bill over the Senate Bill 959. HR 3204 does not provide exemptions for certain types of pharmacy practice nor does it require pharmacies practicing under 503(A) to report their compound activities to the FDA when compounding for drug shortages. PCCA would have hoped for additional revisions to 503(A) to modernize a fifteen year old piece of legislation to reflect the current state of pharmacy compounding. If the current legislation is signed into law, we will continuediscussions with our legislators about this issue.

After carefully reviewing the legislative options, we believe the bill could still have unintended consequences, however, we also believe opposing or delaying the bill would give other interests the opportunity to negatively influence the bill even further.   Therefore, PCCA has decided to be neutral regarding the “Drug Quality and Security Act”.

PCCA is committed to remaining an active participant in legislative issues and continue to represent our members and their patients to ensure access to compounded medications.

Sincerely,

Dave Sparks
CEO
PCCA