Latest Drugwonks' Blog
As seen in The Hill …
Animal health and human health are inextricably linked
The Food and Drug Administration’s long-awaited policy announcement on antibiotic use in food animals has accomplished an almost impossible Beltway feat – just about everyone’s happy about it.
The new policy aligns antibiotic use in animals and humans and eliminates the use of antibiotics as growth promoters, similar to the European ban on antibiotic growth promoters. The FDA’s new guidance requires that all medically important antibiotics used in animal agriculture be administered with the supervision of a licensed veterinarian for therapeutic purposes -- meaning disease treatment, control and prevention. Use for growth promotion will be phased out. Medicines will now be used in animal health much the same way they are by humans –to address disease and under the watchful eye of a licensed medical professional.
FDA’s action is in line with to a letter sent to the White House in July, 2009 by 20 public health advocacy groups, including the Alliance for the Prudent Use of Antibiotics, the Infectious Disease Society of America and the Pew Campaign on Human Health and Industrial Farming. The letter expressed support for “the FDA’s calls for phasing out the use of antimicrobial drugs for growth promotion and feed efficiency, and for requiring that all other uses of these drugs be carried out under the supervision of a veterinarian.”
To achieve those worthwhile goals, the FDA engaged in a consensus-building stakeholder process and, judging by the almost universal positive reaction to the FDA announcement, it was a successful endeavor.
Some claim this is an issue that should be addressed through federal legislation or legal action. However, the collaborative, stakeholder process proved to be superior in at least two ways:
First, it achieved the desired outcome faster. The FDA discussed the various issues at length during the process. Second, the action avoided unintended consequences. Legislative bans on antibiotic growth promotion uses in Europe resulted in increased animal death and disease. While the transatlantic outcomes are the same – eliminating antibiotic growth promoters – the FDA’s collaborative provided for a smooth and savvy transition.
The bottom line is that FDA has begun to implement significant public health change in the most practical way possible. Animal health is inextricably linked to human health. This FDA action minimizes antibiotic use in food animals, maintains the tools necessary to protect animal health and, most importantly, enhances the protection of human health.
Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest and a member of the Animal Health Institute’s Board of Scientific Advisors
Home HIV test should be sold in retail stores, US panel urges
Published May 16, 2012
NewsCore
A Food and Drug Administration advisory panel Tuesday asked the agency to let an HIV test be sold in retail stores so consumers do not have to go to a health facility to get tested for the virus.
The mouth-swab test, made by OraSure Technologies Inc., is sold commercially to health professionals to be used at facilities.
If approved by the FDA, the test results could be obtained in the home like tests for pregnancy and blood sugar. The FDA usually follows panel recommendations.
The test was reviewed Tuesday by the FDA's blood-products advisory panel, which is made up of non-FDA medical experts.
The panel voted 17-0, saying the "projected benefits" of OraSure's in-home HIV test outweighed the "potential risks of false positive and false negative results." The panel also voted 17-0 in support of a question that asked if the data submitted by OraSure showed the test was safe and effective.
If the OraQuick In-Home HIV Test is approved, it would mark the first time that HIV test results could be obtained in the home. Other home HIV tests require a fluid sample to be sent to a laboratory for testing.
About 1.2 million people in the US are infected with HIV, and about 50,000 infections are diagnosed each year, a level that has been stable for a decade. Federal health officials estimate 20 percent of people with HIV do not realize they are infected and risk spreading the virus.
OraSure argues the test would most benefit people at risk who have never been tested or do not get tested regularly.
One concern about the home test is it does not appear as accurate as tests conducted by health professionals. The company conducted a study of the home test in 5,662 people who also took a traditional HIV laboratory test that used blood. Blood tests showed 114 people were positive for HIV. Of that group, 106 reported positive tests via the home test, and eight reported a negative test.
It is not clear if the home test provided a negative result or if people read the test incorrectly. Still, FDA officials said the home-use test would likely encourage more people to get tested. "We believe there would be public-health benefits" of a home-based HIV test, said Richard Forshee, an FDA associate director for research. "But an individual risk remains in the form of an increase in the number of false negatives."
A Catholic university in Ohio said Tuesday it is being forced to end a student health insurance program over the Obama administration's contraception mandate and costs associated with other provisions of the health care overhaul.
Franciscan University in Steubenville, Ohio, said it has so far excluded contraceptive services and products from its health insurance policy for students and will not participate in a plan that “requires us to violate the consistent teachings of the Catholic Church on the sacredness of human life.”
In its decision to drop coverage, the school cited the contraception mandate, but also a requirement that the maximum coverage amount be increased to $100,000 for policyholders -- claiming that would have made premiums skyrocket. A university official told Fox News Radio the students’ basic $600 policy was going to double in cost in the fall and triple next year and that the school’s insurance provider said the increases were the result of the federal Patient Protection and Affordable Care Act.
"This is putting people in a position where they are having to choose between their faith and their morality, and now an unjust cost," said Mike Hernon, the school’s vice president of advancement. "These sorts of regulations from the government are forcing our hand in a way that's really wrong."
Read the full story here.
When it comes to Congressional action on drug shortages, “newer” is not always “better.” An earlier PDUFA discussion draft (House side) would have mandated the FDA to:
… include a list of the drugs that are subject to the requirements of section 506C(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c(a)), as amended by subsection (a), if the manufacture of such drug is to be discontinued, or an interruption of the manufacture of the drug that is likely to produce a drug shortage;”
Nice. Clear. Matching authority and expertise.
The current version reads:
IN GENERAL. -- A manufacturer of a drug subject to section 503(b)(1) -- (1) that is -- (A) life-supporting; ‘(B) life-sustaining; or (C) intended for use in the prevention or treatment of a debilitating disease or condition; and (2) that is not a radio pharmaceutical drug product, a product derived from human plasma protein and their recombinant analogs, or any other product as designated by the Secretary, shall notify the Secretary of a discontinuance of the manufacture of the drug, or an interruption of the manufacture of the drug that is likely to lead to a meaningful disruption in the manufacturer’s supply of the drug, and the reason for such discontinuance or interruption, in accordance with subsection (b).
Very vague as to what drugs fall into these categories and what, precisely, those circumstances might be.
The Senate-side language is equally unclear:
IN GENERAL.-- A manufacturer of a drug -- (1) that is -- (A) life-supporting; (B) life-sustaining; (C) intended for use in the prevention of a debilitating disease or condition; (D) a sterile injectable product; or (E) used in emergency medical care or during surgery; and (2) that is not a radio pharmaceutical drug product, a human tissue replaced by a recombinant product, a product derived from human plasma protein, or any other product as designated by the Secretary, shall notify the Secretary, in accordance with subsection (b), of a permanent discontinuance in the manufacture of the drug or an interruption of the manufacture of the drug that could lead to a meaningful disruption in the supply of that drug in the United States.
Considering the high profile nature of this issue and the need for manufacturers to err on the side of both patient safety and legal prudence, lack of clarity will very likely lead to reporting everything, thus exacerbating a signals-to-noise problem at an already over-burdened FDA.
Perhaps the best solution is for Congress to require the FDA to compile and publish a list of drugs that must be reported to the agency when circumstances leading to potential shortages arise. This would allow companies to determine when they need to contact the FDA – and allow them to do so more swiftly and efficiently. Such legislative authority would also focus the FDA’s energy on the most critical drug shortage situations – allowing them (with their limited staffing resources – it’s worth repeating) to address them with greater skill and alacrity.
Noise proves nothing. Often a hen who has merely laid an egg cackles as if she laid an asteroid.
-- Mark Twain
Just as the Supreme Court is weighing the compensation system for pharmaceutical sales representatives at GSK (will the word "sales" ever be the same?) so too is ... GSK.
I was recently briefed by a senior GSK executive on that topic as well as about the company’s pending agreement in principle with the DOJ.
I wanted to talk details. He wanted to talk about Deirdre Connelly, GSK’s President for North America Pharmaceuticals and her views of a post-settlement company.
His meeting. His agenda.
Specifically, I learned that Deidre’s favorite topic, “is the future and how potential recidivism will not be tolerated.”
GSK, according to my interlocutor, is a company that’s ready to look ahead with some fresh ideas.
We’ll have to wait and see on the specifics (of both the DOJ settlement as well as what those new approaches may be) – but a recent speech by Ms. Connelly (at the CBI 8th Annual Pharmaceutical Industry Compliance Congress) lays out some initial propositions – about values, compliance, and a new model for pharmaceutical representative roles, responsibilities – and compensation.
Here are some snippets from that oration.
Since January of 2009, the Justice Department has reached settlements totaling nine billion dollars against healthcare companies. These cases involved alleged false claims, fraud, and FDA violations.
As someone who decided more than 25 years ago to pursue a career in the pharmaceutical industry, I ask myself: what’s going on? Why is this happening? What went wrong?
The answer, I believe, is that, in some ways our industry lost its way, and failed to fully appreciate the evolving expectations of our stakeholders.
Society holds our interactions with our customers – healthcare providers and payers – to a higher standard. And it should. Society expects our business to be conducted openly and transparently and in a way that does not create even a perception of inappropriate influence.
To be fair, our industry has made significant changes in how we operate over the past several years. What our critics either are unaware of – or choose to ignore – is that our industry adopted the PhRMA Code almost ten years ago, which serves as a baseline for how we should work with healthcare providers and institutions. The industry then strengthened the code in 2009, making additional changes in areas such as meals, continuing medical education, support for educational and professional meetings, and the use of consultants and speakers, among other things.
But negative perceptions remain. Some of this has to do with long-running government investigations, litigation over past practices, and the resulting news coverage that makes it look like we still take doctors on trips to exotic locations –which we don’t. Some of it is because we haven’t done enough to communicate what we do and don’t do. Some of it is because industry bashing is good politics. Some of it is because we still make mistakes. No matter the reasons, at the end of the day, we must regain the public’s trust in our industry.
So, what should we do?
Of course, we must comply with the laws and regulations that govern how we in the pharmaceutical industry are required to operate our business. That is not subject to debate or open to interpretation. It’s a given.
But our customers need to understand – that beyond compliance – we operate from a core set of values that underpins every decision we make and every action we take. A values-based culture creates a framework and a mindset in which compliance with rules and regulations is not the ceiling, but the floor from which our organizations should operate.
In my mind, three key elements make it happen: First, you have to be willing to break the mold and fundamentally change your approach to certain aspects of your business. Second, you must align your resources with your values. And, third, you must demonstrate leadership based on those values.
To help ensure that the behavior of our representatives is consistent with our values, we’ve also decided to break the mold and change the way we provide incentive compensation to our sales representatives.
In the past, like other companies, we based the variable portion of the compensation for our sales force on the volume of prescriptions they obtained in their sales territory. That is no longer the case. We are now in the process of putting in place a new incentive compensation system in which individual sales representatives are not bonused on scripts, but on three factors: an assessment of their scientific and business knowledge; feedback from customers in their region, including demonstration of our values; and overall performance of the business unit they support.
Importantly, we’re shifting our focus from obtaining the next script to providing the information and support our customers want and need. We may not be able to provide all our customers with everything they want, but what we do provide will be aligned with what they need to treat their patients better.
As part of our performance management process, our employees have a values and integrity objective included in their annual performance plans. They are evaluated for not only “what” they do, but also “how” they do it. This enables us to incorporate a behavioral component into our performance evaluation process, further supporting our commitment to the company’s values.
We’ve also made a significant investment in establishing 60 Integrity Champions who provide training and support so that we can further ingrain accountability for values and compliance throughout the business.
Ultimately, you get returns from what you invest in and what you reward.
But I believe the greatest imperative for us, as leaders, is to look forward and examine what more we can do to ensure our practices are in step with societal expectations.
Our customers are watching.
The complete text of Ms. Connelly’s speech can be found here.
The Seventh Circuit Court of Appeals has ruled that Eli Lilly does not owe a former rep overtime.
According to a report in Medical Marketing and Media, “Wednesday's decision, which reversed a lower court's ruling that the rep was entitled to overtime, deals a blow to the Obama administration. The Labor Department had backed the rep’s overtime claims, and the Office of the Inspector General sided with sales reps in Christopher v. SmithKline against GSK which revolves around the same issue: are sales reps considered outside sales teams or more like typical employees?
The focus of these cases turns on what these employees can or cannot do: regulations bar sales reps from taking drug orders from doctors. Plaintiffs say being deprived of that final step puts labor laws on their side, because it marks them as employees, not as outside sales forces, and therefore eligible for overtime.
Pharma companies counter that reps facilitate sales by showing up and talking with doctors about drugs. The companies say these visits trigger sales and are therefore sales calls, which would put the reps in the category of employees who are not eligible for overtime.
Meanwhile, the Supreme Court has yet to choose sides—it heard arguments in Christopher v. SmithKline Beecham April 16, but has not yet issued an opinion.
For those of you following the Plan B saga, here’s the transcript of the April 27th, 2012 hearing in New York Federal Court.
The April 27th hearing was supposed to be about whether Teva could intervene (to protect its 3 year exclusivity based on additional actual use/label comprehension studies FDA had acquired) and the court's order to show cause why the USG should not be held in contempt, but it also touched on the plaintiff's motion for a preliminary injunction/summary judgment and the government's motion to dismiss the case (which the judge denied orally at the hearing).
The most amusing part of the transcript is when the government tries to argue that none of the plaintiffs are 13, so the court can't give relief as to them. There were 13 years old when the case began, but the case has gone on so long they have reached the age of majority.
The judge is scathing of the government's argument, saying "Do you know how long this agency -- your agency has done nothing and then you have the chutzpah to come in here and say that thirteen-year-olds who started the case are of age now." (See page 55.)
The judge is pretty scathing of Secretary Sebelius, referring to her logic as "totally ludicrous" (page 12). He says that if Teva had appealed Sebelius's decision they would have won (page 24), but then later the DOJ lawyer points out that the Sebelius decision is not appealable, since it resulted in a complete response, which is not final agency action -- which the court finds odd (pages 38-43), at one point saying it seems like "blowing smoke."
Later on the judge says, "this whole thing is an artificial construct at odds with common sense” (page 54) and wonders how the argument could be made with a“straight face” (page 55). The judge also talks about how the no one can satisfy the Sebelius criteria because there are not enough 11 year olds who are having sex (pages 43-44). Ouch.
The judge also calls the FDA to task for not denying the citizens petition as soon as he remanded it to them (in 2009), and he thinks that as soon as the agency told Teva they needed to do more studies, FDA should have denied the Citizens petition. (This conversation begins on page 50.)
Yep.
http://www.doh.wa.gov/cfh/immunize/documents/coe2011.pdf
So why is the CDC punting on the whooping cough outbreak in Washingon? Here's the CDC spokesperson on the epidemic:
'Adults and teens need booster shots so they don't give pertussis to the babies in their lives, said CDC spokeswoman Alison Patti
"We want to create a cocoon of protection around them," she said. "We're really worried about keeping babies safe."
Patti emphasized that pertussis isn't spreading because of an anti-vaccine movement. Among possible reasons for the recent spike are that diagnoses in teens and adults are getting better and doctors are doing a better job with reporting, she added.'
This is nonsense. While outbreaks go in five year cycles, the incidence has skyrocketed in places where anti-vaccine sentiment is strongest: including Idaho, New Mexico, Madison, WI, Woodstock, NY and Vermont.
Under Obama, the CDC has been ducking the source of vaccine resistance and in some cases, caving into it. Perhaps its because their anti-sugar allies are also anti-vaccine or because the states essential to the president's re-election are also the one's where the anti-vax movements are strongest..
This is pure speculation on my part. But in any event, the lack of leadership on immunizations at the CDC is troubling. Bad enough that CDC is using cost-effectiveness analysis to decide whether it's worth paying for new vaccines under Obamacare. Ignoring a principal threat to herd immunity is even worse.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
