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At just before 5pm last Friday (April 3), the FDA posted 14 DDMAC warning letters. They can all be found here:
Click Here to Read the Letters
First of all, kudos to the agency for posting them so swiftly. The letters were all released on April 2 and posted on April 3.
DDMAC, timely? What’s wrong with this picture? Or, if you prefer, what’s right?
The next item to consider is the contents of the letters. They all deal with the same topic, “sponsored” Google links.
DDMAC consistent? What’s wrong with this picture? Of, if you prefer …
Consistent because all of the letters not only deal with the same issue of sponsored links, but address them in more or less the same way. Let’s take the letter to Bayer for example:
Here’s how the letter begins:
“The sponsored links cited in this letter are misleading because they make representations and/or suggestions about the efficacy of Levitra, YAZ, and Mirena, but fail to communicate any risk information associated with the use of these drugs. In addition, the sponsored links for YAZ and Mirena inadequately communicate the drugs’ indications, and the sponsored links for Mirena overstate the efficacy of the drug. Furthermore, all of the sponsored links fail to use the required established name. Thus, the sponsored links misbrand the drugs in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA implementing regulations. See 21 U.S.C. 352(a) & (n), 321(n); 21 CFR 201.10(g)(1), 202.1(b)(1), (e)(3)(i), (ii) & (e)(6)(i).”
While the particulars for each of the other 13 letters differ, the basic theme is the same, that the “sponsored links” are not in compliance because they are “misleading” – making “representations and/or suggestions” that DDMAC feels are out of compliance, and fail to present the appropriate risk information.
Now, as all you weathered FDA cowhands know – when it comes to DDMAC letters (and every other piece of FDA communication) – it’s very important to understand what’s in the letter as well as what is not.
These letters are about sponsored links. What does that mean? Sponsored links, as the DDMAC letters illustrate, are those links in the “sponsored” section of a web search (in the case of Google, these are the search results that appear on the upper right hand side of the page). Never more than a few lines, they are teasers. And, not to put too fine a point on it – they are paid for product marketing messages. They are advertisements.
The DDMAC letter to sanofis-aventis is particularly instructive on this point:
“Omission of Risk Information
Promotional materials, other than reminder pieces, which include the name of the drug product but do not include indications or other representations or suggestions relative to the drug product (see 21 CFR 200.200, 201.100(f), 202.1(e)(2)(i)), are required to disclose risk and other information about the drug. Such materials are misleading if they fail to reveal facts that are material in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the
materials. The sponsored links present the following claims (emphasis in original):
* PLAVIX Medication Lowers Risks of Future Heart Attack or Stroke from PAD. See how prescription PLAVIX medication may help patients with recent heart attack, recent stroke, or established P.A.D. at PADfacts.com … “
So, DDMAC is making the point that sponsored links such as these are being considered as “reminder ads” gone wild.
Guidance? What guidance? DDMAC letters should help companies understand what “in compliance” means. These letters do not. In fact, they make things more muddled. After all, “sponsored links” are by no means a new phenomenon.
Podium policy via Warning Letters is not a replacement for clear and concise guidance.
Okay, so wither “guidance?” Consider some official agency direction that is already on the books:
Post-marketing Safety Reporting for Human Drug and Biological Products Including Vaccines
Click Here to Read the Report
“Applicants should review any Internet sites sponsored by them for adverse experience information, but are not responsible for reviewing any Internet sites that are not sponsored by them.”
It’s not a leap of faith to understand the implications (and applications) of this relative to the concept of sponsored Google links.
For example, what about the concept of “clicking thorough” to full risk/benefit information? Let’s look to the GSK letter for that one. DDMAC writes:
“We note that these sponsored links contain a link to the products’ websites. However, this is insufficient to mitigate the misleading omission of risk information from these promotional materials.”
Now, here’s where it becomes less clear. How will this impact regulatory perspectives on branded product websites? What about third party websites that have been constructed with grants (unrestricted or otherwise) from interested parties? What about links and websites for devices and diagnostics?
What about predictability?
Well, that’s harder than it sounds because regulators love ambiguity. Ambiguity is power. And that’s particularly true for DDMAC issues that quickly bump up against the First Amendment. That’s why interpretation of FDA actions is such a vibrant cottage industry. Industry, on the other hand, seeks clarity. They want bright lines. They want to know the rules. They want predictability. This may sound simple, but it has proven to be a fractious bureaucratic kulturkampf within the FDA.
My sources inside the agency (but outside of DDMAC) tell me they were caught by surprise by these new DDMAC letters. What does this mean? Does it expose the probability that this important social media issue was not discussed at higher levels? You be the judge – but you can bet they will be now. In fact, I wouldn’t be at all surprised to see this issue discussed at a sitting of the Risk Communications Advisory Committee.
(In fact, it should have been discussed before the letters were sent out in the first place – that’s what advisory committees are for. But that’s just my opinion.)
Here’s something that isn’t opinion -- sending out Warning Letters isn’t guidance – it’s punitive regulatory action. It’s FDA acting tough without putting in the time and brainpower to explain how to address the perceived problem. That’s not what we need. That doesn’t advance the pubic health.
Regulators change industry behavior by changing the rules of the game. But changing the minds of regulators, having them embrace bright lines rather than broad definitions, is a distinctly more challenging proposition, because changed minds must begin with change agents within the agency itself.
Predictability is power in pursuit of the public health.
Here is a video link to our friendly but fractious (and often funny) forensic foray.
It’s worth watching.
On another note, this is proof positive that two people who hold strong opposing views can have a robust debate that is disputatious, substantial and respectful.
The Center for Medicine in the Public Interest (the public policy institute home of drugwonks.com) is a member of the Health Policy Consensus Group, an affiliation of policy experts from major market-oriented think tanks and others who work together to advance patient-centered ideas for health reform.
That group has many ideas about how to move healthcare reform ahead in an expeditious and responsible way -- but our immediate concern is with many of the programs being both implemented and considered by the new administration.
First do no harm.
To that end we have issues the following statement:
__________________________________________________________
Would the health reform prescriptions offered
by President Obama and Congressional leaders help patients?
From the Health Policy Consensus Group
President Obama repeatedly has reassured the American people, “If you've got health care already, and probably the majority of you do, then you can keep your plan if you are satisfied with it. You can keep your choice of doctor.” Research shows 82 percent of Americans rate the health care they receive as good to excellent.
- A new government health insurance plan
- An employer "play-or-pay" mandate
- A uniform, government-defined package of benefits
- A mandate that individuals must purchase insurance
- A National Health Insurance Exchange extending federal regulatory powers over private insurance
- Federal interference in the practice of medicine through a federal health board, comparative effectiveness review, and other government intrusions into medical decision-making
As to why we explain below why we believe these ideas would diminish individual Americans’ freedom and control over their personal health decisions, please see the complete Statement on Health Reform here.
There are many problems that need to be addressed in the health sector, and the signatories to this statement have written extensively about our ideas for reform. Because the reform agenda is moving rapidly through Congress, we believe the American public should be aware of the likely impact of the policies described in this statement which are under active consideration by elected leaders.
We believe that the proposals put forth by the Administration and Congressional leaders would harm, not help, patients and would not fulfill the goals and promises made to the American people.
Biotech gets short shrift from Obama
His policies don't support entrepreneurial medical innovation.
By ROBERT GOLDBERG
Vice president, Center for Medicine in the Public Interest
President Barack Obama said last month that small businesses "are the heart of the American economy." He promised his administration would do everything it could to help entrepreneurs since they were the "core of America's story."
Yet, Obama's policies are threatening biotechnology – one of the most vibrant and important forms of small business our nation has ever produced.
Medical innovations have added wealth and health to our nation. From 1970-2000, increased longevity added approximately $3.2 trillion per year to national wealth, the equivalent of half of the average annual gross domestic product over the period.
According to a 2004 study by the Milken Institute, biopharmaceutical companies are responsible for creating over 2.7 million jobs across the United States. The industry was directly responsible for $63 billion in real output in 2003 and a total output of over $172 billion when its ripple effect is figured in across other sectors.
The president has increased federal funding for basic research and stem-cell science. With $20 billion a year in research funding, the National Institute of Health is important. But to translate discoveries into treatments will require more than the nearly $60 billion in money currently being invested by pharmaceutical, biotech and venture capital firms on cutting-edge treatments for cancer, Alzheimer's, AIDS, mental illness and heart disease.
That investment is (in real dollars) declining. Less than half of all public biotech firms have six months of cash left for research. For startups the situation is direr, even though the scientific promise of their investment is great.
Yet at every step of the way, President Obama supports policies that will stifle the entrepreneurship that he praises, and which are vital to actually producing real cures.
Obama supports de facto price controls that would allow the "reimportation" of prescription drugs. In essence, this is an effort to force every pharmaceutical and biotech company to sell drugs here at the controlled prices imposed in Canada and Europe.
Yet these are the same price controls that shut down medical innovation in those nations – companies sell their wares there for a small profit, but they don't risk the money to develop new lifesavers for those markets. If reimportation worked to force down prices here, it would also shut down the innovation Obama claims to favor.
Obama is establishing a comparative effectiveness council to slow down the introduction of new medical technologies. This entity would, like similar agencies in England and elsewhere, allows economists to compare old treatments with new ones and then tell doctors how much someone's life is worth – and whether it's worth saving – in order to save money.
The impact on innovation and patient well-being should be obvious. The UK's comparative effectiveness panel said new cancer pills were more effective than debilitating chemo treatments and extended life but still weren't worth paying for. No wonder the UK biotech industry issued a report blaming comparative effectiveness for killing not only people but the incentive for innovation.
Obama wants to apply comparative effectiveness to Medicare and eventually to every health plan. This would delay and ration the elderly's use of breakthrough drugs and ultimately let the government control what drugs and treatments everyone can take. In Europe, over the past 10 years, similar restrictions have caused the development of new drugs to stall. From 1993-97, Europe launched 81 breakthrough drugs; from 1998-2002, just 44. Meanwhile, U.S. drug launches jumped from 48 to 85.
Finally, it is disappointing that Obama made food safety, not medical progress, his number one concern in reforming the Food and Drug Administration. Indeed, Obama added money to the FDA's budget to inspect spinach but not to speed up the approval of breakthrough drugs for spinal cord injuries, multiple sclerosis and rare diseases. The agency has a program using 21st-century science – such as gene and stem cell-based tests – to determine if new medicines work. But Obama has refused to add money for that effort. You can score more political points sticking it to drug and biotech companies than standing shoulder to shoulder with dying patients.
Together, these policies are draining the life out of the biotechnology industry. The president is investing in "green" technologies to promote the environment. Yet, his health care policies will undermine private sector investment in medical innovations critical to solving public health problems related to the aging and growth of the world's population.
For all his rhetoric, thanks to his policies the medical discoveries the president supports will never be translated into economic prosperity or treatments that transform humanity.
Click Here to Read the Full Article
Sorry if I caused any marcomms gyrations.
(But it's still a good idea to replace ambiguity with some clarity in the social media space.)
FOR IMMEDIATE RELEASE
April 1, 2009
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
New FDA Draft Guidance Aims to Improve Health Information Obtained via “Social Media” Websites
The Food and Drug Administration today issued a draft guidance document designed to improve communications to consumers and health care practitioners about health conditions and medical products that they obtain on “social media” Websites such as Facebook, YouTube, Twitter and online bulletin boards. The guidance is the result of FDA research and policy development, and was influenced by the success of the recent social media based peanut recall program.
"We intend to do all we can under the law to make sure that the information conveyed by prescription drug promotion is as useful as possible," said acting FDA Commissioner, Dr. Joshua M. Sharfstein. "Our new regulatory guidance provides new direction to sponsors on how to provide higher-quality health information to the public via social media sites, based on recent evidence on what works and what doesn't. The evidence shows that social media promotions directed to consumers can play an especially important role in helping patients start a discussion about conditions that are often unrecognized and therefore undertreated, such as diabetes, high blood pressure, high cholesterol, depression, and obesity. And we think those discussions should reflect a better understanding of the key risks and benefits of a product. Without participation by pharmaceutical companies in those discussions, there is increased likelihood of false or dangerous information being promulgated throughout the Internet."
According to an FDA study, a majority of interactive agencies surveyed feel that social media product messages increase patient awareness and involvement, and improve compliance. That study also shows that social media-stimulated visits to a physician can help identify a previously undiagnosed condition. Importantly, of patients who visited their doctors because of an online discussion they participated in, 95% actually had the condition the drug treats. That percentage was even greater than that reported among patients who viewed DTC ads on TV.
The draft guidance provides (1) a simple method by which sponsors can insert a notice about reporting adverse events in their posts to social media sites, (2) “safe harbor” conditions that relieve manufacturers of responsibility for reporting adverse events they may hear about on social media sites, and (3) advice for manufacturers on the types of branded and unbranded communications that fall under the rules set forth in the guidance.
"Clear, evidence-based regulatory guidance will help FDA use its limited resources to police the marketplace as effectively as possible," said Sharfstein. "FDA will take action against sponsors whose ads violate the law by presenting false or misleading information to the public via social media sites. Our new draft guidance is intended to help responsible companies comply, for the benefit of the public health. If they don't, we now have an even stronger basis for pursuing enforcement actions."
More on this to be sure.
As you have surely seen, a group of the usual suspects, often referred to in the media as “a group of leading doctors and researchers” (WSJ) is calling on medical associations to forego funding from drug and device companies.
At the just-completed
And healthcare in
Maybe not.
According to ACC’s chief executive Jack Lewin, drug and device companies, “have zero impact on the content of any program here” He also said banning industry support could force a spike in registration fees, discouraging doctors from attending.
You can look it up under “Pyrrhic Victory.”
If you work for a pharmaceutical company, ask yourself this question: What business are you in? To the average American, you are in the business of selling. To survive and thrive you must be in the business of advancing the public health. And to do that you must be seen as both teacher and expert.
By: Marilynn Marchione, Ap Medical Writer – 2 hrs 38 mins ago
ORLANDO, Fla. – A single daily pill that combines aspirin and four blood pressure and cholesterol medicines has passed its first big test, potentially offering a cheap, simple way to prevent both heart disease and stroke.
The experimental "polypill" proved as effective as nearly all of its components taken alone, with no greater side effects, a major study found. Taking it could cut a person's risk of heart disease and stroke roughly in half, the study concludes.
This "one-size-fits-most" approach could make heart disease prevention much more common and effective, doctors say.
"Widely applied, this could have profound implications," said Dr. Robert Harrington, an American College of Cardiology spokesman and chief of Duke University's heart research institute. "President Obama is trying to offer the greatest care to the greatest number. This very much fits in with that."
The polypill also has big psychological advantages, said Dr. James Stein of the University of Wisconsin-Madison.
"If you take any medicines, you know that every pill you see in your hand makes you feel five years older. Patients really object to pill burden," and respond by skipping doses, he said.
The study was led by Dr. Salim Yusuf of McMaster University in Hamilton, Ontario, and Dr. Prem Pais of St. John's Medical College, Bangalore, India. Results were presented Monday at the cardiology college's conference in Florida and published online by the British medical journal Lancet.
The study tested the Polycap, an experimental combo formulated by Cadila Pharmaceuticals of Ahmedabad, India. It contains low doses of three blood pressure medicines (atenolol, ramipril and the "water pill" thiazide), plus the generic version of the cholesterol-lowering statin drug Zocor, and a baby aspirin (100 milligrams).
Participants were about 2,000 people at 50 centers across India, average age 54, with at least one risk factor for heart disease — high blood pressure, high cholesterol, obesity, diabetes or smoking.
Four hundred were given the polypill. The rest were placed in eight groups of 200 and given individual components of the pill or various combinations. Treatment lasted 12 weeks.
Compared to groups given no blood pressure medicines, the polypill lowered systolic blood pressure (the top number) by more than 7 units and diastolic (bottom number) by about 6 — comparable to levels for people given the three drugs without aspirin and the cholesterol drug.
LDL, or bad cholesterol, dropped 23 percent on the polypill versus 28 percent in those taking the statin drug separately. Triglycerides dropped 10 percent on the combo pill versus 20 percent with individual statin use. Neither pill affected levels of HDL, or good cholesterol.
Anti-clotting effects seemed the same with the polypill as with aspirin alone.
Side effect rates also were the same for the polypill as for the five separate medicines.
"That was a big surprise. I would have expected five times the number of people to have side effects," said Dr. Christopher Cannon, a cardiologist at Harvard-affiliated Brigham and Women's Hospital in Boston who had no role in the study.
Collectively, the results show the polypill could cut the risk of heart disease by 62 percent and the risk of stroke by 48 percent, based on what previous studies show from lowering risk factors by these amounts, the study concludes.
Polycap's maker sponsored the study, and Yusuf has been a paid speaker for several makers of heart drugs. No price for the polypill is available, but its generic components cost only $17 a month, Cannon said.
A bigger study is now needed to see whether the polypill actually does cut heart attacks and strokes, he wrote in a commentary in the medical journal.
"It won't be for everybody," he said. Some people would be overtreated by getting medicines for conditions they don't yet have, such as high cholesterol. Others may be undertreated by too-low doses in the combo pill. Several polypills of different strengths may be needed, Cannon said.
"We have to be cautious about assuming that one size fits all," Stein said. "Treating risk factors is a lot like cooking — the ingredients count."
A polypill also would need federal Food and Drug Administration approval, even though all of its components have long been sold separately. The dosing issue could become a regulatory nightmare, Cannon warned.
"A final challenge: would the availability of a single magic bullet for the prevention of heart disease lead people to abandon exercise and appropriate diet?" he wrote in the medical journal.
That could make the risk of heart disease worse, and undo the good of the drug, Cannon said.
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.
