Latest Drugwonks' Blog
Did The Obama Administration Throw The FDA Under The Bus?
Susan Wood quit her
job as an assistant commissioner for woman’s health at the Food and Drug
Administration in 2005 because she thought political, not scientific, forces
were delaying efforts to make the Plan B emergency contraceptive available
without a prescription. Four years later, she rejoiced when she was present to
watch President Barack Obama sign a statement that said decisions
in his administration would be based on science, not politics.
Now she says she is
beyond disappointed. Obama’s Secretary of Health
and Human Services, a member of his cabinet, Wednesday made a new decision to
prevent a further expansion of Plan B’s over-the-counter use, this time to
adolescents, overruling not only FDA staffers but also the drug agency’s
commissioner, Margaret Hamburg. Although the HHS secretary,
Kathleen Sebelius, was within her legal authority under the 1938 law that
created the FDA, this is the first time a presidential administration has ever
publicly overruled the FDA in this manner.
“This is contrary to
the scientific integrity memo signed by Obama,” Wood says. “It’s contrary to
the whole principal of making decisions based on science and evidence.”
Wood says the
decision sets “a terrible precedent for the whole breadth and depth of the FDA”
and that the “medical and scientific expertise to make such decisions and
recommendations truly resides in the FDA,” not elsewhere in Sebelius’
department. The only silver lining, Wood says, is that by publicly standing up
to Sebelius with a letter of protest posted on the FDA’s web site, Hamburg may
have prevented the decision from demoralizing rank-and-file FDA staffers.
President Obama
asserted yesterday that he “did not get involved in he process” but backed
Sebelius’ decision. Whatever the merits of the plan B decision, using Sebelius’
power in this way may tarnish what has been one of the Obama administration’s
great, pro-business achievements: Hamburg’s successful transformation of an
embattled FDA, scarred and damaged by the controversies over big pharmaceutical
industry scandals like Vioxx and Avandia, into an agency that is approving new
medicines and a near-record clip and clearly and efficiently deals with new
controversies as they crop up.
The question is
whether this decision is a one-off, or a change in the way medicines are
regulated. Could future negotiations with drug companies be weakened by the
fear that the FDA commissioner would be overruled? And even if Sebelius is
always going to back up Hamburg on every other regulatory decision, what about
future administrations?
David A. Kessler, who
headed the FDA between 1990 and 1997, praises the Sebelius and Hamburg for
being transparent by airing their disagreement in public. And he says that for
many decisions like Plan B, even if they are based on science, reasonable
people can disagree. “There’s no scientific textbook where you can look up the
answer,” he says. “You can respect people coming out on different sides.” His
worry is not about whether 11-year-olds should need a prescription for Plan B,
but about what happens in the future if decisions traditionally made by FDA
scientists become cabinet-level political issues.
“My concern is just
that it’s lousy precedent,” says Kessler. “The last thing you’d want is to have
this be seen as precedent so any new drug applicant sees the decision-maker as
the secretary. That’s not the way it’s ever worked or should work.”
Others put their
opinions even more bluntly. “The decision on Plan B by the secretary represents
an unprecedented level of interference in the FDA process and puts the country
on a slippery slope toward politicization of science,” says Steven Nissen, a
physician who has been critical of the FDA in the past. “Future political
leaders may choose to overrule the FDA on much more critical decisions.” Nissen
said he was not speaking for his employer, the Cleveland
Clinic, where he is chairman of cardiology.
Peter Pitts, a former
FDA associate commissioner who now works at the Center for Medicine in the
Public Interest, a right-leaning think tank that receives drug industry
funding, echoed those views, calling the decision “outrageous.” Pitts says: “It
opens up the hornet’s nest of companies lobbying HHS, of members of Congress
lobbying HHS. It’s a Pandora’s box of a decision.”
Not everyone agrees
Sebelius’ move will have such far-reaching effects. For one thing, political
pressures have in the past been brought more privately on the FDA – it’s not
clear that the public argument between Hamburg and Sebelius really changes
things. Ramsey Baghdadi, a founder at Prevision Policy,
a consultancy, and an editor at the RPM Report, says Plan B is “a unique
situation that demonstrates how FDA has to grapple with the intersection of
science, politics and policy all at once.”
Baghdadi says it is
possible that the Plan B controversy could lead Hamburg to exit the FDA. He
calls this “highly speculative,” but notes that Hamburg was appointed when
former Senator Tom Daschle was expected to head HHS; she was not a Sebelius
pick.
Plan B is thought to
generate only about $200 million for its maker, the generic drug giant Teva,
and the new regulation was seen as only a minor issue in terms of public
health. But the emergency contraceptive, which reduces the chance of pregnancy
after unprotected sex by half, is one of a series of issues that have made the
FDA into a political football over the past decade, often at times when the
agency was without leadership.
The controversy over
Merck’s painkiller Vioxx, which increased patients’ risk of heart attacks,
resulted in congressional hearings that, in turn, resulted in tougher new drug
approvals and voluntary industry limits on drug promotion. Safety issues and
badly conducted clinical trials with the antibiotic Ketek helped make
antibiotic approvals so tough that drug companies seemed to abandon the field
en masse. The backlash over the diabetes drug Avandia led to new hurdles for
heart safety for medicines to lower blood sugar. The drama has hurt the drug
industry.
Hamburg’s leadership
has more or less turned this around. She handled the controversial decision
over whether to withdraw Roche’s approval to market Avastin for breast cancer
with aplomb, backing her scientists that the data did not support the drug’s
use. Although bad for Roche, many in the drug industry saw this as a positive
step, because there were fears that not revoking Avastin’s approval would have
made it harder for experimental drugs to be approved in the future.
In the fiscal year
that ended Sept. 30, the FDA approved 35 new medicines, the second-highest
count this decade. New initiatives appear to be making it easier for companies
to get clear guidance as to what they need to get new drugs approved. For the
first team in years, the FDA seems anything but rudderless – a change that is
great for the pharmaceutical industry, which depends on strong, clear, and
consistent regulation. The Plan B decision may have set back that turnaround,
and, if saner heads don’t prevail in rebuilding the wall around the FDA, it
could do long-term damage to medicine in the years to come.
The morning after Secretary Sebelius' unprecedented overruling of the FDA's decision one thing is clear -- the door is now wide open to anyone who has a beef over any decision rendered by Peggy & Co.
The line forms to the left.
When asked directly if the White House had weighed in on this matter, the HHS press office refused to comment. In other words, yes. Can you imagine the hue and cry if this had taken place during the previous administration?
Having served as Associate Commissioner at the FDA during the first round of Plan B hysteria, I can personally attest to the heat and scrutiny it generated. And appropriately so. The significant difference is that debate was internal to the agency. There were differences of opinion -- but the decisions (whether you agree with them or not) were FDA decisions.
Leaving aside the peculiar politics of reproductive health, this action by the Secrerary must be reversed. Left standing it will severely undermine the authority of the FDA and embolden those who think that political arm twisting should be used to influence agency decisions.
Katy -- bar that door!
The FDA would have a hand in writing regulations and guidances for accelerated approval. But it seems to me that the agency should not be the one to determine clinical benefit especially when the scientific community and patients can do that. It should just verify that products are doing what they were designed to do. The pushback on progressive approval suggests that legislative action may be required to truly bring the FDA into the 21st century.
Yesterday I was pleased to chair Day 1 of the Social Media for Pharma event in New York City.
First off, this and similar events can no longer (and should no longer) be identified as “pharma” events. Witnessing today’s attendance by and active participation of members of the medical technology (née “device”) community along with a full table of dietary supplement marketers, makes it pretty clear this and similar symposia are healthcare events.
And that’s a good thing.
A few memorable moments:
Greg Kueterman and Amy O’Connor of Eli Lilly & Company gave a splendid presentation on their health policy blog Lillypad (www.lillypad.lilly.com). One of their most important points (not rocket science, but rarely discussed) is that, when it comes to healthcare in the social media space – it can be about things other than product marketing and that metrics are more than about volume. It’s not about the top ten, but rather the right ten. Amen.
Greg asserted that he's “the Justin Bieber of healthcare social media.” Not sure what that means, but it does seem to be an off-label claim.
William Martino (Saatchi & Saatchi Wellness) and Shermon McMillan (Chattem) – henceforth forever known as Shermon/William – painted an interesting portrait of social media and the OTC launch (and subsequent marketing) of Allegra.
Ned Russell (Saatchi & Saatchi Wellness) pointed out that the oft-quoted FaceBook development maxim of “move fast and break things,” couldn’t be more antithetical to regulated healthcare communicators (note – not marketers, but communicators). My comment was that this might explain the tone deafness of the world’s largest social media platform has to issues such as moderated user-generated commentaries. (Also note that the FCC didn’t find FaceBook’s swiftness to cast aside privacy issues so kosher either.)
And, while we’re on the subject, why does FaceBook allow “drugs from Canada” pages. Did they not get the memo from Google and the DOJ?
Tai Spargo of NORD discussed their new social media efforts in creating a plentitude of orphan disease sites minus any participation of the biopharmaceutical industry. She also noted (and rightfully so) that there is no rare disease too small for social media. To illustrate her point she displayed the FaceBook page “Cats in Sweaters.” Meow.
Check it out if you are so inclined at http://www.facebook.com/pages/Cats-in-sweaters/183921988289175. Idle hands indeed do the devil’s work.
Sharon Landa (Johnson & Johnson) and Erica Wittes Schlack (Communispace) discussed the design and utility of private (read, “closed”) social media communities. Fascinating. Two comments to pass along, “Feedback is about the brand, but discovery is about the consumer” (utility) and “Diversity is for conversation but similarity is for cohesion (design).
There was also much chatter about how to make social media programs work along side of “traditional communications initiatives.”
Rather than calling them “traditional,” perhaps we should label them as “legacy” programs.
And we all know what happens to those.
America's Health Insurance Plans is out with a new report on the state of health savings accounts. Among the findings: Lower-income individuals open HSAs at a greater rate than do higher income groups - with an average income in the mid-$50,000 range - and the amount of money that individuals have accumulated in their accounts has grown over time, and the amount of money being rolled over from one year to the next also has increased.
Click here to read the report.
The New York Daily News (12/3, Pesce) reported, "A new FDA-approved hangover cure has hit the market." The over-the-counter medication, dubbed Blowfish, "combines 1,000 milligrams of aspirin, 120 milligrams of caffeine and a stomach-soothing agent into two effervescent tablets taken the morning after a night of heavy drinking." Blowfish "costs $2.99 for a single dose, or $11.99 for a six-pack" and "is currently available in Ricky's NYC stores or online at ForHangovers.com."
The website of WCBS-TV New York (12/5) reports, "Just in time for the holidays, the FDA approves a purported hangover remedy. Blowfish, created in the West Village, is promised to get rid of all your hangover symptoms within 15 to 30 minutes." FOX News Radio (12/4, Rappoport) added that that the drug "combines aspirin, caffeine and a stomach soother into two effervescent pills to be taken the morning after a night of partying." The remedy's creator Brenna Haysom "says the pill is only intended for people who had one too many, not binge drinkers."
At CMPI’s “PDUFA without the Politics” Capital Hill Briefing, Dr. Tim Franson (President, USP Convention, former Vice President, Global Regulatory Affairs, Eli Lilly & Co., and one of the “father’s of PDUFA”) mentioned the Hawthorne Effect – “that which is measured gets accomplished.”
Which begs the question – should more things in PDUFA V be measured or measured with more robust deliverables?
Are “meetings” sufficient promises – or are actions more desirable? Specifically – are meetings about a benefit/risk grid enough or should there be a date-certain for a regulatory instrument to be operational?
Should PDUFA V be exclusively about process? What about provision?
Speech is conveniently located midway between thought and action, where it often substitutes for both. – John Andrew Holmes
Always listen to the experts. They’ll tell you what can’t be done and why. Then they do it. – Robert Heinlein
On Tuesday the Center for Medicine in the Public Interest (www.cmpi.org ) hosted a Capitol Hill panel entitled, “PDUFA without the Politics.” I was the moderator and was honored to be joined by a panel of peerless nonpareils that included Vincent J. Ventimiglia, Jr (Former Assistant Secretary for Legislation at the US Department of Health and Human Services), Paul T. Kim (Former Deputy Staff Director for health policy for Senator Edward M. Kennedy), Michele J. Orza (Former Assistant Director of the Health Care Team at the Government Accountability Office), and Tim Franson (Former Vice President, Global Regulatory Affairs, Eli Lilly & Co., President, USP Convention). The Honorable Michael C. Burgess, M.D. (Vice-Chairman, Subcommittee on Health, U.S. House of Representatives) offered remarks as well.
The participants were pithy, poetic, and pragmatic.
We will shortly post videos of all the aforementioned presenters. In the meantime, here’s a short news story from Drug Information Daily:
Lawmakers Plan to Use PDUFA V Bill to Ease Conflict Rules for Advisory
Panels
Lawmakers plan to attach a bill easing financial conflict rules for FDA advisory panel members to legislation reauthorizing the Prescription Drug User Fee Act (PDUFA), a congressional leader says.
Rep. Michael Burgess (R-Texas) introduced H.R. 3206 last month and said Tuesday it would be attached to the measure authorizing PDUFA V, yet to be introduced to Congress. H.R. 3206 would eliminate the existing financial conflict rules for panelists, opening the door for committee members with greater expertise on the products they discuss.
Burgess, vice chair of the House Energy and Commerce Health Subcommittee, offered similar legislation during consideration of PDUFA IV in 2007, but it was voted down along party lines. With his Republican party now in control of the House, he may have an easier time gaining approval of the bill.
Speaking at a PDUFA V briefing for Capitol Hill staffers hosted by the Center for Medicine in the Public Interest (CMPI), Burgess said there are about 10 strong candidates for legislation to tack on to PDUFA V. One possibility is a bill addressing the issue of drug shortages, he said.
Another likely candidate is a bill to increase incentives for antibiotic makers, according to Foley Hoag lobbyist Paul Kim.
Proactive Lawmakers
Also at the briefing, Peter Pitts, former FDA associate commissioner and president of CMPI, urged Congress to be more proactive in changing the technical letter the FDA and drugmakers agreed to during PDUFA negotiations earlier this year. Specifically, Pitts called for more programs and agency action to address transparency and striking a better risk-benefit balance in product reviews.
Following these recommendations might mean altering the package the FDA and industry ratified, which has only happened once in the previous four PDUFA bills.
Recently, David Wheadon, PhRMA's senior vice president for scientific and regulatory affairs, said the package includes a "robust set of programs" to provide an objective measure of risk-benefit analysis at the agency.
http://www.cbsnews.com/8301-18560_162-57330802/hard-times-generation-families-living-in-cars/
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.
