Monday, September 30, 2013
What happens to the FDA in a government shutdown? September 30, 2013 | By Damian Garde Read more: What happens to the FDA in a government shutdown? -
With hope for congressional compromise waning by the hour, the federal government is bracing for its first shutdown in 17 years, and for the FDA, that means furloughing about half its staff and ditching duties it can no longer afford. What that spells for drug developers with eyes on approval, however, remains murky.
If the government shuts down come Tuesday, the FDA will lose 6,620 employees, about 45% of its staff, and the agency would have to cease many inspections, enforcement actions and monitoring operations, also suspending the "majority" of its internal lab research, according to a Department of Health and Human Services briefing.
As for advisory panels, PDUFA dates and the agency services that affect the drug development world, things are more opaque. While the government is quite clear that only mission-critical, life-and-death work will
continue, DHHS also said that the "FDA would continue limited activities related to its user-fee funded programs," which would include drug approvals.
Read more: What happens to the FDA in a government shutdown? - FierceBiotech http://www.fiercebiotech.com/story/what-happens-fda-government-shutdown/2013-09-30#ixzz2gRSKPWls
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Challenge: September 30, 2013 A challenge to animal owners--Ask as many questions as possible about compounded preparations
I challenge all animal owners to be proactive in the future and ask their veterinary some essential questions when having their animals treated. If medications are prescribed, asked if they are compounded preparations. Ask why a compounded preparation is being used? Is there a commerically available? Ask why it is not being used? If compounded preparations must be used ask questions about where the medication is compounded. Ask who does the compounding. Ask what qualifies the pharmacy and pharmacists to do the compounding. And then be more specific and ask what qualifies the pharmacy or pharmacists to compound animal medications. What special training did the pharmacist receive? Very few pharmacists have the specific knowledge and expertise to compound animal medications. You need to make sure your veterinarian is using a pharmacist that has this specialized knowledge and training; otherwise, it could be very harmful to your animal and even result in the death of that animal. Also ask the veterinarian about the testing of the compounds. If the veterinarian doesn't know ask him or her to find out, or ask the question directly to the the pharmacists. Ask as many questions as you can think to ask about compounded preparations that will be used on your animal--it could save your animals life.
Second Question of the Day September 30, 2013 How much total money has been pumped into legislators (state and federal) in an attempt to gain favorable compounding legislation?
Sunday, 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
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
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
comments from Dr. Kenneth Woliner
Saturday, September 28, 2013
* 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
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).
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
completeban, 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 websitespecifically 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.
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.
The Compromise Compounding Bill passed via voice vote, today. It goes back to the Senate this coming week. IACP is continuing to meet with Senate offices to address language we believe does nothing for quality standards and instead jeopardizes patients' access to the compounded medications on which they depend. You can still do something about this! Go to http://lnkd.in/bMyJv98 and let your congressional contacts know why this Bill does not help you the patient. Thanks for supporting compounding pharmacists!
Comment from Dr. Kenneth Woliner
Congress often operates on the principle of "Half a loaf is better than none." IACP is opposing the bill because they don't want any FDA involvement, even if it is a "voluntary registration". As a patient, I'd be concerned because how the heck am I going to know if my doctor is injecting me with a medicine produced by a compounder that did register? As a physician, I don't see any special benefit from using a registered facility. No immunity from lawsuits caused by tainted drugs, for example. And the anti-aging clinics run by businessmen (not physicians), will still pick the cheapest supplier, not the one that registers. This bill is similar to Vietnam, where the U.S. "declared victory and left.". The Congress will pass this bill to say they did something, hoping another tragedy doesn't happen before the next election cycle. When another tragedy does happen (actually, a few more tragic events in a row), then, and only then would this do-nothing Congress actually do something on Question of the Day September 27, 2013 How can a voluntary federal law covering compounding pharmacies possibly work? Wouldn't that be like saying the Controlled Dangerous Substance Act is now voluntary?
Published: 27 September 2013 01:26 PM
Updated: 27 September 2013 01:31 PMA compromise bill that would increase federal regulation of pharmaceutical compounders has been agreed to by sponsors in the House and Senate, and could face a key vote as soon as tomorrow in the House energy and commerce committee.
Its fate, hanging in the balance over the next few days, underscores how difficult it can be to craft new regulations for businesses well-armed to fend off what they see as needless federal intrusion and costly red tape, even if safety advocates say the changes are needed to keep patients safe from deadly mistakes.
Earlier this week we looked at mounting pressure to bring compounders under tighter federal scrutiny in the wake of last year's disastrous meningitis outbreak that left dozens dead after contaminated steroids were injected in patients across the country.
Two versions had been put forth - a tougher bill that had passed a senate committee and a draft bill in the House that had drawn lighter opposition from the industry.
The compromise essentially would create a class of compounders called "outsourcing facilities" that would be regulated and inspected by the U.S. Food and Drug Administration. But the compounders would have the choice of designating themselves as outsourcing facilities, making the tougher scrutiny voluntary. In return, they'd be offered a kind of FDA seal of approval that competitors who don't submit to the scrutiny wouldn't have.
A committee report on the key provisions of the bill reads:
SEC. 102. OUTSOURCING FACILITIES. This section would add a new section 503B to the Food, Drug, and Cosmetic Act (FFDCA) allowing a facility that is engaged in the compounding of sterile drug products to register with the FDA as an outsourcing facility. Such facilities would be inspected by the FDA on a risk-based schedule and required to follow current good manufacturing practices (cGMPs) in addition to having to meet other standards and requirements. SEC. 103. PENALTIES. This section would add several prohibited acts associated with compounded drugs, including the intentional falsification of prescriptions for such products. SEC. 104. REGULATIONS. This section would require the Secretary to follow the formal rulemaking process when promulgating regulations to implement this title. SEC. 105. ENHANCED COMMUNICATION. This section would require the Secretary to facilitate meaningful communication between the agency and the State boards of pharmacy about concerns raised, or actions taken, against compounding pharmacies.
But The Houston-based International Academy of Compounding Pharmacists opposed the initial Senate bill and continues to have "many concerns" about the compromise, according to a post to members on its website.
I've got calls into several Texans who serve on the Energy and Commerce Committee, and will update this post when I hear back about who is supporting what.In a sign that the compromise has the support of the GOP leadership, the committee posted a link to more than a dozen letters sent by supporters of the compromise bill.
Griffith, Green, DeGette Support Bipartisan, Bicameral Compounding Agreement Friday, Sep 27 -Congressman Morgan Griffith (R-VA), Congressman Gene Green (D-TX), and Congresswoman Diana DeGette (D-CO) participated in a series of Energy and Commerce hearings on the drug compounding issue. They recently introduced the Compounding Clarity Act (H.R. 3089), and today signed on as cosponsors of the Drug Quality and Security Act. The Drug Quality and Security Act, which incorporates some of the Compounding Clarity Act, is a bipartisan, bicameral first step to help ensure the safety of compounding drugs. It also will work to prevent a national public health crisis like the 2012 fungal meningitis outbreak tied to the New England Compounding Center (NECC). 64 deaths and 750 confirmed cases of fungal meningitis resulted from tainted steroid injections from the NECC.Griffith said, “The Drug Quality and Security Act is a first step at clarifying current law. It eliminates perceived confusion that existed as a result of court decisions on advertising related to compounding drugs and adopts the notification provisions that were in the Griffith-Green-DeGette Compounding Clarity Act. The Drug Quality and Security Act leaves a large portion of existing law intact. It also leaves many areas of practice where clarification may still be needed, particularly as it relates to office use, repackaging, and nuclear pharmacies. Along with my colleagues, I will continue working to oversee the FDA’s interpretation and implementation of this law.” Green said, “The Drug Quality and Security Act is a positive step forward toward enhancing public health and ensuring that compounded drugs are safe and dependable. I am proud to have worked with my colleagues Reps. Griffith and DeGette in pressing for enhanced FDA oversight of compounding. While I believe the FDA dropped the ball with regards to the NECC, with this law they must succeed where in the past they failed. This bill still lacks clarity in many important areas: office use, how nuclear pharmacies are regulated, and repackaging of sterile products. I look forward to working with my colleagues to provide meaningful oversight of the FDA to make sure another NECC type outbreak never happens again and to make sure they are using the type of enforcement discretion necessary to preserve patients’ access to critical medicine.”DeGette said, “The deadly fungal meningitis outbreak that sickened hundreds across the United States last year represented a tragic failure of the compounding drug manufacturing system and made clear we must have a stronger and more effective regulatory framework to oversee that system. That is why I was proud to join with my friends and colleagues Congressmen Griffith and Green earlier this month in introducing legislation that ultimately served as a foundation for the Drug Quality and Security Act introduced today. Today’s bipartisan, bicameral bill will take important steps forward to develop a more robust regulatory framework that can save people’s lives. I know my colleagues and I look forward to the passage of this bill and to continuing to work to ensure we take every step possible to secure the compounding drug manufacturing chain, and protect the lives of American patients.”
Friday, September 27, 2013
U.S. House may take up pharmacy compounding bill on Saturday
BY MARK MORRIS
The Kansas City Star
With the U.S. House expected Saturday to consider a compromise bill to regulate pharmacy compounding, interest groups have weighed in on the merits of the legislation.Read more here: http://www.kansascity.com/2013/09/27/4513137/us-house-may-take-up-pharmacy.html#storylink=cpy
IACP Member Alert: IACP: COMPROMISE COMPOUNDING BILL WILL NOT ADVANCE QUALITY AND SAFETY!
The International Academy of Compounding Pharmacists (IACP) believes that the compromise compounding bill that has emerged from Congress will not protect the American public; contains significant gaps because it does not provide key definitions to govern compounding practice; and does not take into account any of the input from the compounding profession provided to Congress over the last year.
Click here to read more http://bit.ly/18vhnx9
Question Three of the Day, September 27, 2013, What happens when you try to apply the Compounding Quality Act (a part of the Drugs Quality and Security Act) to a situation in the future that is like the NECC outbreak?
Assume NECC does not elect to be an outsourcing facility. Assume that the FDA nonetheless after receiving information from the states attempts to take enforcement action against NECC. What do you think NECC's response would be? We are so glad you showed up to save all these people FDA, come on in, look around, gather evidence, do your job?? I think not. I think you would get the same response as in the past--FDA we didn't elect to be under your authority so go away--FDA would then have to go to court and hope for the best! And hope that they could get court action before anyone died.
Letters of Support for H.R. 3204, the Drug Quality and Security Act
September 27, 2013