Latest Drugwonks' Blog
- Responding to unsolicited requests
- Fulfilling regulatory requirements when using tools associated with space limitations
- Fulfilling post-marketing submission requirements
- On-line communications for which manufacturers, packers, or distributors are accountable
- Use of links on the Internet
- Correcting misinformation
Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed. The public will be notified officially when any guidance is issued via Federal Register announcements.
My colleague Peter Pitts has written smartly on the subject of social media. If you read between the lines of the non-issuance, Peter's prior observation that there is a lot that the FDA will and cannot regulate suggests that any guidance will be a non-event.
Beside, as I point out in my book tabloidmedicine, most of what defines the risk and benefits of a medicine on line is a result of what others are saying or spreading in ways that will always be unregulated by the FDA. So what's a company to do?
1.Fill the void with tools that give consumers information and the ability to determine in partnership with their physicians what's best.
2. Ask people to volunteer participating in certain social networks, only ask and enter when invited.
3. Respond quickly and proactively to scaremongering, counterfeiting scams and hype.
Here’s a significant potential PDUFA addition – adding patient perspectives to the FDA’s analyses of drug application reviews.
In the minutes of the 11/22 PDUFA negotiating session, the FDA said that information about patients’ understanding of existing treatment tools is considered valuable, but is not consistently available during the review process.
This new initiative would place in front of frontline reviewers the views of patients who, for example, are willing to live with more serious side effects or safety concerns because they have failed on previous treatments and have no other options.
The agency said it wants to host meetings with review divisions and relevant patient advocacy groups to talk about available treatment options and unmet needs. That information would be used to help draft guidances for specific indications.
This is a real advance and will significantly enhance the role of the FDA’s Office of Special Health Issues. Bravo.
And speaking of greater input, industry is keen to bring more clarity and transparency to the approval process. Specifically, industry officials want a more structured risk-benefit formula included in PDUFA V and asked that the agency begin using it in its decision-making (similar efforts under way at the EMA).
CDER Director Janet Woodcock, “We’re all for that and we’ve been working on that, the industry’s been working on that, other academic parties have been working on that. So I think we will come up with something there.”
Office of New Drugs Director John Jenkins has said on more than one occasion that the framework should be simple and support sound expert judgment, not replace it.
According to Jenkins, such a model could improve predictability and consistency, support more structured discussions and provide concise descriptions of evidence and the risk-benefit implications.
Amen.
It's time to see all these good words turned into legislative deeds. And the sooner the better.
A few thoughts on PDUFA V before we settle in for the holiday break.
Two Teams. As negotiations proceed, it becomes increasingly obvious there’s an emerging duality – the FDA’s Part B “asks” and industry’s legitimate worries over what was promised, but not delivered, from PDUFA IV.
Perhaps both agency and industry should create two teams so that both sets of issues can be addressed in a timely and comprehensive manner. Special teams, as they say, win ballgames.
Carrots and Sticks. Everyone wants to be rewarded for promises delivered – but perhaps its time for some hurt to be written into the system for promises unfulfilled. PDUFA is a partnership and partnerships are built on mutual respect and understanding. When one side rewrites the rules while the game is in play, that’s not partnership – it’s a thorny thicket of unintended consequences. Not to put too fine a point on it, but predictable timing for first cycle decisions count.
When the agency can “stop the clock,” PDUFA dates lose all meaning. It’s the same argument used in Inherit the Wind to dispute the length of Earth’s “first day.” After all, since the Sun hadn’t been created yet, the first day could have been 24 hours or 24 billion years long. Sometimes a review feels just like that.
And finally …
First Principles. It’s time to remember why PDUFA exists in the first place. And that reason is predictability. PDUFA V will either provide more predictability or more excuses. The latter is not an acceptable choice for industry – nor will it be tolerated by the 112th Congress.
For all concerned – and particularly for patients – PDUFA V needs more resonant cowbell.
I was also pleased to have my book Tabloid Medicine launched and want to thank Peter, Dr. Weber, Mario and Ben for their support! Here's my observation on the new google.com 3-D body browser
www.technewsworld.com/story/Google-Really-Gets-Under-Peoples-Skin-71487.html
tabloidmedicine.com
WikiLeaks: Cuba banned Sicko for depicting 'mythical' healthcare system
Authorities feared footage of gleaming hospital in Michael Moore's Oscar-nominated film would provoke a popular backlash
By Amelia Hill
guardian.co.uk, Friday 17 December 2010
A WikiLeaks cable reveals that when Michael Moore's film was shown to Cuban doctors, they were 'disturbed at the blatant misrepresentation of healthcare in Cuba'.
Cuba banned Michael Moore's 2007 documentary, Sicko, because it painted such a "mythically" favourable picture of Cuba's healthcare system that the authorities feared it could lead to a "popular backlash", according to US diplomats in Havana.
The revelation, contained in a confidential US embassy cable released by WikiLeaks , is surprising, given that the film attempted to discredit the US healthcare system by highlighting what it claimed was the excellence of the Cuban system.
But the memo reveals that when the film was shown to a group of Cuban doctors, some became so "disturbed at the blatant misrepresentation of healthcare in Cuba that they left the room".
Castro's government apparently went on to ban the film because, the leaked cable claims, it "knows the film is a myth and does not want to risk a popular backlash by showing to Cubans facilities that are clearly not available to the vast majority of them."
Sicko investigated healthcare in the US by comparing the for-profit, non-universal US system with the non-profit universal health care systems of other countries, including Cuba, France and the UK.
It was nominated for an Oscar for best documentary feature but was also castigated for being naive and tendentious.
The cable comes from the United States Interests Section in Havana (USINT) – staffed by US foreign service personnel and local staff employed by the department of state, the unit is formally a section of the Embassy of Switzerland, although it operates independently of the Swiss in virtually all but protocol respects.
The secret 2008 cable is based on reports from the USINT's foreign service health practitioner (FSHP) of her conversations with local people, unauthorised visits to Cuban hospitals, and experience of helping USINT American and Cuban personnel access healthcare.
The cable describes a visit made by the FSHP to the Hermanos Ameijeiras hospital in October 2007. Built in 1982, the newly renovated hospital was used in Michael Moore's film as evidence of the high-quality of healthcare available to all Cubans.
But according to the FSHP, the only way a Cuban can get access to the hospital is through a bribe or contacts inside the hospital administration. "Cubans are reportedly very resentful that the best hospital in Havana is 'off-limits' to them," the memo reveals.
According to the FSHP, a more "accurate" view of the healthcare experience of Cubans can be seen at the Calixto Garcia Hospital. "FSHP believes that if Michael Moore really wanted the 'same care as local Cubans', this is where he should have gone," the cable states.
A 2007 visit by the FSHP to this "dilapidated" hospital, built in the 1800s, was "reminiscent of a scene from some of the poorest countries in the world," the cable adds.
The memo points out that even the Cuban ruling elite leave Cuba when they need medical care. Fidel Castro, for example, brought in a Spanish doctor during his health crisis in 2006. The vice-minister of health, Abelardo Ramirez, went to France for gastric cancer surgery. The neurosurgeon whoheads CIMEQ [Centro de Investigaciones Médico-Quirúrgicas] hospital – widely regarded as one of the best in Cuba – came to England for eye surgery, returning periodically for checkups.
"After living in Cuba for two and a half years, treating numerous Cuban employees at USINT, and interacting with many other Cubans, the FSHP believes … preventive medicine in Cuba is a by-gone ideal, rather than the standard practice of care," the memo concludes.
* On his website today Michael Moore has said that Cuba did not ban his documentary, Sicko
Some thoughts from the Ghost of Healthcares Yet to Come.
What business are you in? To most people, including most of your industry colleagues, 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.
And partner.
Partner with physicians, certainly. With patients, definitely. But also with government. You must walk the tenuous tight rope of being both regulated entity and public health colleague with the regulatory mandarins who watch over you.
Your internal legal and regulatory departments will gasp. But you will gain. And it can (indeed must!) be done.
As ever greater regulatory oversight for your marketing practices comes into play across the globe, you must rethink both the type and timeframe for successful communications. Rather than focusing strictly on short-term product sales programs, you must now create a firm foundation for trust built on the substrate of public health progams.
Consider the FDA’s “Safe Use” initiative. In addition to adverse event reporting, the FDA wants to communicate with physicians and patients about how drugs and devices can be used safely, appropriately. Because a product used safely is a safer product. But the FDA needs allies. It has no budget for public health outreach beyond the bully pulpit. Who will step up to the plate to work with the agency? What are the perceived barriers that you face in doing so? If you want the agency to be both regulator and colleague, so too must you be prepared to play those identical roles. It takes two to tango.
Similarly in the EU, the rules are changing when it comes to the Brussels concept of Information to Patients (ITP). Consider this verbiage from a recent report from the EU Parliament:
“Member States authorities may not be in a position to fully address patients’ needs in terms of the substance of information and the access via different means … The pharmaceutical industry has the potential to be an important source of information to respond to the growing demand for more and better information by patients and to help reduce the current information gap, provided that there will be adequate rules to ensure reliability, objectivity, and quality of information.”
We are running out of failed 20th century marketing alternatives. It’s time to embrace public health communication programs as a powerful tool for corporate reputation, payer relations, physician education, patient empowerment, and yes – product sales.
But this strategy also requires a new appreciation of time. No longer can you only design programs for short-term unit sales purposes. That only reinforces your perception as greedy marketer. The 21st century demands a new paradigm. It won’t be easy. And it can’t be achieved through lip service. You can’t talk yourself out of something you acted your way into.
The roadside of healthcare sales strategy is strewn with the carcasses of failed marketing alternatives. Advancing the public health in concert with the governments with whom you do business is not only the right thing to do – it’s the smart thing as well.
I do not believe that the FDA took cost into consideration in its decision to remove Avastin’s breast cancer indication. Nevertheless, the unintended consequences are going to be deadly.
Medical decisions need to be left to patients and their doctors. They're the ones with access to crucial information needed to make the right decision about treatment options. Conceiving of medicine as one-size-fits-all is dangerous and ignores the individual biological nuances inherent in the U.S. patient population.
Of course, doctors could still provide Avastin for breast cancer treatment by prescribing it "off label." But an FDA denial means that public insurance programs like Medicaid and Medicare could refuse pay for the drug. Private plans would almost certainly follow suit.
In fact, evidence suggests that insurance companies are rooting for the FDA to de-list Avastin for advanced breast cancer. Already, the Regence Group, a regional health insurer in the Pacific Northwest, has published a policy listing Avastin for breast cancer as "medically unnecessary." And this policy was applied retroactively!
Without insurance coverage, patients would have to bear the full brunt of Avastin's price tag, which typically runs about $8,000 a month. Technically, women would still have access to this life-saving medication. But the only ones who will actually get to use it are the very slim minority with great financial means.
Worse still, revoking Avastin's approval would stifle medical innovation. Virtually every oncologist believes that the future of cancer treatment lies in complex, biologic drugs like Avastin. These kinds of drugs differ from traditional treatments in that they can be hypercustomized to meet the specific medical needs of individual patients. They also tend to be more effective.
By revoking Avastin's approval, the FDA would effectively eradicate the financial incentive for drug companies to develop advanced treatments like it. We'd lose out on an entire generation of cures.
Eli Lilly & Co. President and CEO John Lechleiter was the sole representative of the biopharmaceutical industry at President Obama's Wednesday meeting with business leaders on how to encourage U.S. job growth and economic recovery.
During the meeting, Lechleiter discussed the "life sciences innovation hub" that has grown up in Lilly's home state of Indiana as a potential model for promoting innovation across the country, according to a company statement.
Let’s pick up on that theme and strive to make the 2011 health care discussion all about innovation – because that’s what it really is all about.At Tuesday’s White House confab on intellectual property, Homeland Security Secretary Janet Napolitano declared that eliminating counterfeit pharmaceuticals has become a top priority for federal customs agents and prosecutors, and they expect it to remain high on their agenda next year.
This came as a surprise to many (including many at the FDA).
Nevertheless – good and important news.
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.
