Latest Drugwonks' Blog
In the immortal words of Theodore Roosevelt, “When you are in a hole, stop digging.”
I refer, of course, to the FDA’s embarrassing “Bad Ad” program. After the initial rollout last year in which 33,000 health-care providers were informed about the program, an aggressive agency media effort, brochures, and medical meeting outreach the initiative has resulted in some skin in the game … one letter … for “Derma Smoothe Body Oil.”
At best this effort isn’t, um, cost effective.
At worst, it’s compliance through secret commination. Anonymous e-mails from people who may or not be physicians denouncing ads and sales presentations to a FDA star chamber? Really? Whatever became of transparency. What’s next? Anonymous adverse event reporting?
The “Bad Ad” program is a bad idea for so many reasons – not the least of which is that it seeks to deputize people who don’t understand the law. In the Old West this was more generally referred to as a posse, or worse – a lynch mob.
Secret e-mails are nothing short of electronic lettres de cachet and have no place in official FDA policy. A smart move by the FDA would have been to allow the program to quietly wither away.
Instead, the agency is going on the offensive – making a bad idea even worse by holding it up for broader public scrutiny that will, undoubtedly further embarrass the agency and attract Congressional scrutiny.
Witness this media alert (I am not making this up):
FDA CONSUMER HEALTH INFORMATION – April 28 Webinar: Bad Ads Program
The pharmaceutical industry spends nearly three times as much on advertising to health care professionals as it does on advertising to consumers.
Responsible promotional efforts can give health care professionals valuable information about the latest drug treatments. But not all promotions are accurate and balanced.
Through its Bad Ads Program, the Food and Drug Administration (FDA) asks health care professionals for help in making sure the promotion of prescription drugs is not false or misleading.
Learn how the Bad Ads Program helps protect the public during a 30-minute webinar.
An opportunity to ask questions will follow the presentation.
When: Thursday, April 28, 12:00 p.m. (ET)
Length: 30 minutes
Where: To join the webinar, see the instructions at
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm249817.htm
Host: Division of Drug Marketing, Advertising, and Communication within FDA's Center for Drug Evaluation and Research
Featured speaker: Catherine Gray, Pharm.D., of the Division of Drug Marketing, Advertising, and Communication within FDA's Center for Drug Evaluation and Research.
This webinar is part of a series of online sessions hosted by different FDA centers and offices. The series is part of FDA Basics, a Web-based resource aimed at helping the public better understand what the agency does.
If you want a more detailed discussion of the “Bad Ad” program’s failure, have a look at the article, “FDA's 'Bad Ad' Program Generates One Warning Letter in First Year” in the current edition of Advertising Age.
The complete article can be found here.
As the weather turns warmer and you’re looking for some beach reading, may I recommend FDA’s, “Strategic Priorities 2011-2015: Responding to the Public Health Challenges of the 21st Century.”
And therein the first issue. If the FDA views it’s job as only responding to challenges, that needs to change. The FDA needs to be a change agent – to drive change.
As the bard said, “Action is eloquence.”
The good news is that, under “Vision,” the report reads as follows:
FDA is dedicated to world-class excellence as a science-based regulatory agency with a public health mission. We aim to provide effective and innovative leadership — both domestically and internationally — to protect health, prevent illness, prolong life, and promote wellness.
Leadership. Crucial. Both domestic and international. Absolutely.
There are many crucial initiatives (and I am pleased to report that advancing regulatory science is given a lot of ink). But since we are dealing with the future here, the report is lacking in, what we might call, PDUFAbulousness.
Here’s what the report says about “accountability” --
Consistent with our strong commitment to public service, we will maintain the highest degree of individual and professional accountability in the quality and ethical conduct of our work. Currently, we set measurable goals and openly monitor performance within the agency to make sure we continue to meet our commitments. We hold staff members and executives accountable for achieving organizational goals through annual performance plans that are aligned with our strategic priorities. And we monitor program performance by holding quarterly meetings with program managers and agency executives and sharing program performance data with the public through a new initiative called FDA-TRACK. We understand the importance of FDA's work to the health and welfare of our nation, and we will continue to hold ourselves accountable for delivering on the responsibility.
Hurrah. But one must add, “yes, but additional Congressional oversight might help too.
There seems to be an inability (or a desire?) to openly discuss the importance and urgency of collaboration with industry. Consider this segment under the header, “Innovation/Collaboration” –
We have gained substantial knowledge through more than 100 years of building regulatory programs to ensure the safety and integrity of foods, medical products, and cosmetics. But we also recognize that the promises of science and technology require us to seek new approaches to performing our mission, particularly because competition for scarce public resources makes it difficult to simply scale-up past solutions to meet rising demands. By investing in the field of regulatory science, FDA is fostering innovations that we hope will enhance our effectiveness and productivity for years to come.
We cannot achieve our vision and address the challenges of the 21st century by working alone. To make rapid and efficient improvements in public health and drive innovation, we must harness the best ideas from a broad range of stakeholders and leverage resources through collaboration with other federal, state, and local regulatory and public health agencies; non-government organizations; consumer and patient organizations; academic medical centers and research universities; the private sector; and the public. For example, FDA is collaborating with state and local food safety authorities to develop standards and training that will establish a more integrated and coordinated national food safety system.
One assumes that by “the private sector” the agency means “regulated industry.” So why don’t they say so? Why the need for code language. At the end of the day, if you can’t say it, you won’t do it. This is particularly disturbing relative to the Critical Path Initiative. And here’s a question – why do the words “Reagan/Udall not appear anywhere in the report?
The full report can be found here.
And enjoy the read.
Good news! The UK’s Code of Practice regulator has issued guidance on social media and other digital communications tools.
Bad news! There’s precious little relevance for American marketers.
Nevertheless …
The PMCPA has put together a Q&A document to explain how digital communication fits into its existing regulations. It took this step, rather than amend UK pharma’s self-regulatory Code, because “there have been few complaints about digital communication.”
Ah, our transatlantic cousins doth protest too little!
The Q&A document explains the place of digital communication tools within the existing rules, which ultimately comes down to companies can use digital media if they stick to the Code. It also adds particular emphasis on the Code’s existing ban on promoting prescription-only medicines to the public. “Therefore, pharmaceutical companies need to identify ways of utilising digital communications whilst complying with this restriction."
The PMCPA’s Q&A can be found here.
Obama Panel to Curb Medicare Finds Foes in Both Parties
By ROBERT PEAR
WASHINGTON — Democrats and Republicans are joining to oppose one of the most important features of President Obama’s new deficit reduction plan, a powerful independent board that could make sweeping cuts in the growth of Medicare spending.
Mr. Obama wants to expand the power of the 15-member panel, which was created by the new health care law, to rein in Medicare costs.
But not only do Republicans and some Democrats oppose increasing the power of the board, they also want to eliminate it altogether. Opponents fear that the panel, known as the Independent Payment Advisory Board, would usurp Congressional spending power over one of the government’s most important and expensive social programs.
Under the law, spending cuts recommended by the presidentially appointed panel would take effect automatically unless Congress voted to block or change them. In general, federal courts could not review actions to carry out the board’s recommendations. The impact of the board’s decisions could be magnified because private insurers often use Medicare rates as a guide or a benchmark in paying doctors, hospitals and other providers.
Last week, in his speech on deficit reduction, Mr. Obama said he wanted to beef up the board’s cost-cutting powers in unspecified ways should the growth of Medicare spending exceed certain goals. Supporters say the board will be able to make tough decisions because it will be largely insulated from legislative politics.
Lawmakers do not agree. Representative Paul D. Ryan, Republican of Wisconsin and chairman of the House Budget Committee, called it “a rationing board” and said Congress should not “delegate Medicare decision-making to 15 people appointed by the president.” He said Mr. Obama’s proposal would allow the board to “impose more price controls and more limitations on providers, which will end up cutting services to seniors.”
Senator John Cornyn, a Texas Republican who introduced a bill last month to repeal the Medicare board, said the president’s proposal “punts difficult decisions on health spending to an unelected, unaccountable board of bureaucrats.”
Representative Allyson Y. Schwartz, a Pennsylvania Democrat prominent on health care issues, said: “It’s our constitutional duty, as members of Congress, to take responsibility for Medicare and not turn decisions over to a board. Abdicating this responsibility, whether to insurance companies or to an unelected commission, undermines our ability to represent our constituents, including seniors and the disabled.”
Ms. Schwartz signed up on Friday as co-sponsor of a bill to repeal the board.
The purpose of the panel, according to the health care law, is to reduce the rate of growth in Medicare spending per beneficiary. The law sets annual goals — “target growth rates” — for Medicare spending below the average of the last 15 years.
Board members will be subject to Senate confirmation — no easy feat in the current political climate. Terms are six years. Members can serve no more than two full consecutive terms. The White House has yet to submit any nominations for the board.
“Why have legislators?” asked Representative Pete Stark of California, the senior Democrat on the Ways and Means Subcommittee on Health.
In some ways, Mr. Stark said, expanding the power of the board could be as bad as giving vouchers to Medicare beneficiaries to buy private insurance. “In theory at least, you could set the vouchers at an adequate level,” he said. “But, in its effort to limit the growth of Medicare spending, the board is likely to set inadequate payment rates for health care providers, which could endanger patient care.”
Representative Shelley Berkley, Democrat of Nevada, said she wanted to repeal the Medicare board. “I have great faith that this administration can put together a strong, independent and knowledgeable board,” Ms. Berkley said, but she said she had less confidence in future administrations.
Mark Parkinson, president of the American Health Care Association, which represents nursing homes, said his members disliked the board because it would allow Congress and the president to “subcontract out difficult decisions.”
Still, the idea of a more potent Medicare board could be a live option if the White House insisted on it in budget negotiations with Congress.
Mr. Obama said last week that he would “reduce wasteful subsidies and erroneous payments,” cut spending on prescription drugs and take other steps to save $500 billion in Medicare and Medicaid by 2023. “But if we’re wrong and Medicare costs rise faster than we expect,” he said, the Medicare board would have “the authority to make additional savings by further improving Medicare.”
The president’s proposal would set stricter goals for Medicare spending and establish some type of automatic cost-cutting device as an “enforcement mechanism,” but Mr. Obama did not say exactly how it would work.
Kathleen Sebelius, the secretary of health and human services, described the board as a backstop to “ensure that health costs are reduced.” The board might not have to take action if the president’s other proposals slow the growth of Medicare spending, she said.
The board grew out of proposals by Mr. Obama and Senator John D. Rockefeller IV, Democrat of West Virginia.
“Medicare payment policy should be determined by experts, using evidence, not by the undue influence of special interests,” Mr. Rockefeller said.
AARP, the American Medical Association and the American Hospital Association voiced concern about the president’s latest proposal.
“Relying on arbitrary spending targets is not a good way to make health policy, especially when decisions may be left to the unelected and unaccountable,” said A. Barry Rand, chief executive of AARP, the lobby for older Americans.
Under the law, the board cannot make recommendations to “ration health care,” raise revenues or increase beneficiaries’ premiums, deductibles or co-payments. This increases the likelihood that the board will try to save money by trimming Medicare payments to health care providers.Oodles of fascinating and important data on the use of medicines in the United States hot off the presses from the IMS Institute for Healthcare Informatics.
And the policy implications are enormous.
Some tidbits to jump start your cogitation process:
* Medicare Part D beneficiaries filled 871Mn prescriptions in 2010, up 6.4% and accounting for nearly 22% of all prescriptions.
* Spending on branded drugs totaled $229Bn, but declined by 0.7%, while spending on unbranded generics increased 21.7% and branded generics by 4.5%.
* Spending on medicines mainly dispensed by primary care physicians grew by 0.5%, while those medicines primarily used by specialists grew by 4.8%.
* Small molecule spending totaled $240Bn, an increase of 0.5% as biologics grew by 6.6%, amounting to $67Bn.
* Spending on drugs through retail channels increased by 2.0%, while institutional channels rose by 3.0%.
* Oral forms of medicines declined by 0.1%, but spending on injectables increased by 5.7%.
* New therapy starts for 17 chronic conditions declined by 3.4Mn patients in 2010.
* 3.2Mn more patients started their therapy with a generic while 6.6Mn fewer patients started therapy with a brand.
* Continuations and refills within 17 chronic therapy areas increased by 6.7Mn in 2010.
* Generic continuations increased by 11%, or 67.8Mn in 2010, and now represent about two-thirds of all continuations.
* The number of brand continuations declined by 12% or 61Mn prescriptions in 2010.
* The top 5 classes in 2010 based on spending were oncologics ($22.3Bn), respiratory agents ($19.3Bn), lipid regulators ($18.7Bn), antidiabetes (16.9Bn) and antipsychotics ($16.1Bn).
* Absolute spending growth gains were highest for antidiabetes, antipsychotics, respiratory agents, HIV antivirals and autoimmune disease.
The complete report can be found here.
Roche has managed to reverse the European Medicines Agency's rejection of use of Avastin in combination with capecitabine for treatment of first-line metastatic breast cancer.
While this is a different indication than the one under appeal with FDA, the success of overcoming the regulator's concerns with a re-presentation of the data and an oral defense can only be confidence boosting as Genentech prepares for a similar interaction with FDA on combination use with paclitaxel, which is supported by better data.
The CHMP issued a positive opinion on April 14 on the indication for use with capecitabine, though with a limitation. The summary of product characteristics will restrict use to patients in whom other chemotherapy options, including taxanes or anthracyclines, is not considered appropriate. Further, patients who have received taxane or anthracycline-containing regimens in the adjuvant setting within the last 12 months should also be excluded, CHMP decided.
CHMP's original decision not to allow the indication was issued Dec. 16, 2010 - the same day that FDA similarly decided against a label expansion for use in combination with capecitabine, but more importantly, also announced it was moving to withdraw the metastatic breast cancer indication for Avastin in the U.S.
The initial breast cancer approvals were based on a strong progression-free survival advantage when used with paclitaxel chemotherapy in the E2100 study. Roche subsequently submitted other studies with different chemotherapy combinations - AVADO with docetaxel and RIBBON1 with capecitabine (Roche's Xeloda).
But those other studies failed to live up to the magnitude of the benefit in E2100. EMA had granted a full approval for Avastin use in combination with paclitaxel and decided the new findings did not impact that determination. FDA, however, had issued an accelerated approval on the condition that the other studies confirmed the benefit. When that didn't happen, it decided to rescind the approval - an action Genentech is now appealing.
The proposed label expansions based on the AVADO and RIBBON1 studies were denied by both EMA and FDA. While Genentech's efforts in the U.S. are currently aimed at keeping the paclitaxel indication, in Europe Roche requested a re-examination of the capecitabine indication.
The closing speaker at least week’s PhRMA annual meeting (aka, the “Pharmitzvah”) was Renaissance Man Fareed Zakaria. He gave a wonderful view of the current global economic and political landscape and was in equal parts equally euphoric about the potential and brutally honest about the challenges. Most interesting were his views on the changing nature and role of the nation state.
His was the only presentation that permitted audience participation and I was fortunate enough to ask the first question, “What is the role of the 21st century nation state when it comes to the future of healthcare?”
His answer was as dynamic as it was simple, “The x factor is innovation.”
Specifically, he believes that for a nation to be a global healthcare leader, said nation must invest its national treasure in innovation. He chose as exemplars Singapore, China, India and South Korea. The percentage of public wealth invested by the United States doesn’t even begin to match up with that fearsome foursome. Zakaria also pointed out that the difference between research facilities in Beijing and Cambridge isn’t quality … it’s cost.
In other words, not only are other nations investing more – they’re getting more bang for the investment yuan. All this at the same moment that President Obama disrespects pharmaceutical innovation by suggesting that we reduce the patent life of biologics from twelve years to seven.
In his closing remarks, PhRMA Chairman Chris Viehbacher summed it up nicely, “The question isn’t will our companies be successful? It’s will they continue to be successful in the United States?”
To be or not to be, that is the question.
It certainly puts the slings and arrows into perspective.
Greetings from the 53rd annual PhRMA Annual Meeting in jaunty Jersey City. No beach. No golf. No swag. Just a lot of content.
Some samplers from the Pharmitzvah bima:
PhRMA Chairman (and sanofi-aventis chief) Chris Viehbacher, “As I was walking up to the podium, I was asked if I needed anything. I said, how about a President and Congress that understands the need for a research-based pharmaceutical industry.”
Quite germane and timely considering President Obama’s speech on Wednesday. (For more on that speech see here).
Viehbacher teed-up the meeting by calling on all present to embrace “the three t’s” of truth, trust and transparency. He also mentioned that, alas, there is not (at least as of yet) “a billing code for prevention.” Amen Brother Chris.
Later on we heard a pretty dynamic speech from Governor Chris Christie who insisted that he is (and we should all be) about “results over politics.” Amen Brother Chris.
Governor Christie was followed by our 42nd President, William Jefferson Clinton, who came on stage saying that he wanted to say something nice about the Governor, “but didn’t want to ruin his (Christie’s) reputation.” He then proceeded to give a rambling (by which I mean, charitably, eclectic) speech. Whatever he was paid it was too much -- unless he was paid by the word.
The luncheon speaker was Mike Krzyzewski (“Coach K”) who gave a very stirring and emotional talk, largely about his experience coaching the Olympic and World Championships basketball teams. His philosophy of “standards not rules” resonated. (And his jibes about Kobe Bryant – who reneged on a promise to attend Duke after high school – were priceless.)
John Castellani, now eight months into his job as PhRMA President, captured the frustration of the crowd when, in commenting on the current political environment, quoted Oscar Wilde -- “A cynic knows the cost of everything and the value of nothing.” Nuff said.
Amen Brother John.
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.
