Latest Drugwonks' Blog
Which brings us to the FDA and the future of medical innovation.
A few years ago I had the honor of discussing both topics with Nobel Prize Laureate Joshua Lederberg. Actually, to be accurate, I mostly listened and took notes at the feet of the great man.
When I asked him about FDA's role in 21st century medical science, Dr. Lederberg responded that the real question should be, "Is innovation even possible?"
To that end, have a look at this very interesting and challenging cover story from this week's edition of BioCentury. Titled, "Regulatory Innovation," it makes some keen observations and offers some siginificant food for thought.
Is innovation even possible? Let's hope so.
In an upcoming position paper the Infectious Diseases Society of America suggests that overuse of antibiotics could be controlled via a REMS-like approach – or even an actual REMS.
Interesting idea, because something new must be done. The problem of antibiotic resistance is a real, urgent, and relatively silent public health crisis. For those who rant about the influence of DTC advertising on the doctor/patient dialogue -- it doesn't even hold a candle to a parent's plaintive plea for a prescription when their child has an ear ache.
In the past, FDA has worked with the CDC on consumer education programs such as “Cough, Sniffle, Sneeze – No Antibiotics, Please." But such efforts have met with only modest success (and that’s being generous).
If it takes a REMS to drive the safe and appropriate use of antibiotics, then so be it. Burdensome on docs, yes – but they have nobody to blame but themselves.
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TO BE FOLLOWED BY CMPI'S OWN SEMINAR: TIPS ON HOW TO DATE A DRUG REP
Counterfeit medicines are a real problem – and quantifying that problem is, well, a real problem. How do you estimate criminal activity in ways other than a body count? “Show me the dead Canadians” (as Senator Bernie Sanders is so fond of saying) is not an excuse to do nothing. And purposely derailing the international fight against the false profits of fake medicines via the spanner of "definition" is unconscionable.
Here are four excellent new articles (two from the Wall Street Journal, one from USA Today and the fourth from the Washington Post) that remind us that counterfeit medicines are an important public health issue here at home and around the world.
The first WSJ piece can be found here, the next here, the USA Today story here and the Post’s take here.
While counterfeits are tough to measure, it doesn’t mean that we can ignore the problem. To belittle the problem because we cannot substantiate the volume is unwise. If we wait to count the bodies – we have only ourselves to blame.
I think it is silly to pursue this approach. In the first place, making something prescription does nothing to limit abuse. Indeed, the sharing of prescribed medications is rampant. Secondly, there are other OTC medications that cause many more problems than cough medicines with DXM. That being the case, why not put every OTC that is abused back into prescription or behind the counter. Let's start with aspirin, Vivarin, Red Bull. Why not just ban everything that could possibly lead to adverse events or dependency.
Our poll shows that the first responders and the adults who interact with kids daily (teachers) have bigger issues. Before deciding to require the policing of another medication because it was in the news, the FDA should consider the perspective of those who already have responsibilities for keeping our kids safe. Instead of regulating in this instance the FDA could be educating about the safe and proper use of all medications.

By: Tevi Troy
President Barack Obama announced in his State of the Union address “a new initiative that will give us the capacity to respond faster and more effectively to bioterrorism or an infectious disease — a plan that will counter threats at home and strengthen public health abroad.”
Eight months later, Health and Human Services Secretary Kathleen Sebelius has come out with a report launching the initiative. It does not just call for additional spending, as most federal initiatives seem to do, but for a reconsideration of our life science development process, with a specific call for clearing up bottlenecks that hold up new countermeasures to combat a host of biological threats.
In trying to move the report from paper to policy, the administration may find that some of its most implacable opponents are its staunchest allies, while putative allies may cause the administration heartburn.
“The review repeatedly revealed that aspects of the current regulatory framework and unmet need for regulatory science present both perceived and real barriers for developers seeking to enter the MCM arena,” the report found. In other words, companies looking to create new lifesaving products find the product development process both intimidating and difficult.
To address this, according to the accompanying HHS press release, “HHS will make a significant investment to provide FDA scientists with the resources to develop faster ways to analyze promising new discoveries and give innovators a clear regulatory pathway to bring their products to market.”
There is little doubt that bureaucratic hiccups and “bottlenecks,” as the report calls them, make the development process for new medical products — including drugs, vaccines, biologics and devices — longer than it needs to be. It takes about 10 years and $1 billion to bring a new pharmaceutical product to market, making such an investment only available to large or well-funded entities. One longtime career staffer told me while I was HHS deputy secretary that he never understood why industry complained about the Food and Drug Administration until he began working on trying to develop and acquire new countermeasures through BARDA, the Biomedical Advanced Research and Development Authority, which manages Bioshield.
Two years ago, I produced an HHS report detailing strategies to approach bottlenecks in the life science development process, which I shared with the incoming administration.
It is noteworthy, however, that a Democratic administration is coming up with these findings, as criticizing pharmaceutical companies has become a staple Democratic attack. Both John Kerry in 2004 and Barack Obama in 2008 sent barbs their way, and congressional Democrats such as Henry Waxman have long been critical of the companies as well.
Many congressional Democrats, as well as other Pharma critics on the left, will not want to embrace Sebelius’ drive to clear up FDA bottlenecks — and they may be uncomfortable with the funding for the countermeasure enterprise as well.
The new administration initiative calls for $2 billion in funding as “Democrats on Capitol Hill have tried repeatedly to cut funding for the BioShield program to pay for other domestic priorities,” according to Congressional Quarterly’s Julian Pecquet. If the House succeeds in its efforts to cut $2 billion out of this area, the new initiative could be scuttled before it even gets off the ground.
It also is interesting that the report somehow fails to acknowledge the administration that made the greatest strides in encouraging the development of our current countermeasures.
The report notes that “the federal government began work over a decade ago, during the Clinton administration, to develop and stockpile medical countermeasures against biological threats.” Although the report acknowledges Bill Clinton by name, things that happened in the most recent decade are characterized by a sentence saying that “events after Sept. 11, 2001 led to an acceleration of those efforts.” These efforts included, as the report acknowledges, a new smallpox vaccine, the purchase of anthrax antibiotics and vaccine, and countermeasures against botulinum toxin.
Other important developments recognized by the report include the creation of Project Bioshield for development and procurement of countermeasures and the creation of the pandemic flu preparedness plan. Both were major achievements of the Bush administration, as were the creation of a new HHS office of preparedness and response, as well as BARDA itself.
The report’s inartful and passive “after Sept. 11” construction appears to be a kind of Soviet method for referring to actions undertaken by the Bush administration without actually mentioning George W. Bush’s name. The Obama administration may be loathe to acknowledge this, but in calling for clearer regulatory pathways and more funding for developing and acquiring medical countermeasures, it may be angering some key allies, as well as embracing an important part of the Bush legacy.
Sebelius and other federal officials appeared at a press briefing to discuss issues involved in enrolling more children in the two health care programs following Sebelius's announcement in February of an initiative aimed at enrolling 5 million additional children within five years.
A report by the Urban Institute published Sept. 3 in the online journal Health Affairs found there were about 7.3 million uninsured children on an average day in 2008, of whom 4.7 million were eligible for Medicaid or CHIP but not enrolled.
Of the 4.7 million children, 3 million had family incomes below 133 percent of the federal poverty level, 1.2 million had family incomes of 133 percent to 200 percent of poverty, and 500,000 had incomes above 200 percent of poverty, said the report, "Who And Where Are The Children Yet To Enroll In Medicaid And The Children's Health Insurance Program?"
Medicaid and CHIP enrollment rates varied across states from 55 percent to 95 percent, and 10 states had participation rates close to or above 90 percent, the report said.
Thirty-nine percent of eligible uninsured children (1.8 million) lived in just three states-California, Texas, and Florida-while 61 percent (2.9 million) lived in 10 states, the report said.
Overall, the report estimated that the national rate of Medicaid and CHIP participation for children was 81.8 percent in 2008.
"This new data will help us to focus our efforts and our grant funding where they are most needed," Sebelius said. "We now have a much better sense of where most uninsured children live, and which communities may need more help."
Currently, health coverage is available to children in families with incomes up to about $45,000 per year in nearly every state, Sebelius said.
"Nothing is more important to our future than the health of our children," she said. "No child should have to skip a doctor's appointment or go without the medicine they need because their family can't pay."
"I'm challenging everyone, from my state and federal counterparts, to local governments and community-based organizations, to health centers and school districts, to faith-based groups and Indian tribes, to take this conversation about children's coverage to the next level-to find and enroll those 5 million kids," she added.
Connecting Kids to Coverage Challenge
Sebelius in February announced a new initiative aimed at enrolling children eligible for Medicaid and CHIP. She challenged advocates and policymakers to enroll those eligible for the programs but not enrolled and set forth ways that could be achieved.
The initiative, dubbed Connecting Kids to Coverage Challenge, dovetails with the Children's Health Insurance Program Reauthorization Act (CHIPRA) of 2009.
The act gave states additional tools to help increase children's enrollment in Medicaid and CHIP. The tools included outreach and enrollment grants and bonus payments to states that adopt five of eight enrollment and retention strategies and states that experience Medicaid enrollment increases that exceed target growth rates, according to the Urban Institute report.
States also were given "Express Lane" options, which allow them to use administrative data from other programs such as the Special Supplemental Nutrition Program for Women, Infants, and Children to facilitate enrollment, the report said.
The act also allowed states to use federal dollars to cover legal immigrant children who had been in the United States fewer than five years, and it provided states with additional federal funds to cover more children, the report said.
"By February 2010, one year after CHIPRA became law, a number of states had either expanded eligibility for coverage or introduced improvements to their enrollment and retention processes," the report said.
"By April 2010, the federal government had awarded $50 million in outreach grants, including $40 million to organizations in forty-two states and an additional $10 million for targeting Native American children," the report said.
"These policy changes are expected to change the composition of the population of children enrolled in public coverage and raise participation rates among children who are already eligible," it added.
CHIPRA and the Patient Protection and Affordable Care Act (Pub. L. No. 111-148) provide $120 million for grants designed to promote enrollment and retention strategies that will increase the prevalence of health coverage, according to HHS.
17 Groups Signed On
Sebelius said 17 national organizations and a number of states have agreed to sign on to the "Connecting Kids" challenge. The organizations, ranging from the United Way to the American Academy of Pediatrics, represent a broad base of organizations who are working to enroll children in health insurance, HHS said.
The Urban Institute report said the recession and state budget problems could hamper state efforts to promote greater enrollment and retention among eligible children.
The new health care law will help boost coverage, but "it is not clear how much higher participation can be in the states that already have rates greater than 90 percent, given the dynamic nature of family circumstances and eligibility for public coverage," the report said.
"Without strong economic growth, states may be reluctant to seek aggressively to increase enrollment among eligible children in the near term, or even to maintain recent coverage improvements," the report stated. "The recently enacted extension of enhanced federal Medicaid matching rates through the first half of 2011 may encourage states to implement new policies or maintain existing policies aimed at increasing Medicaid/CHIP participation among children," it added.
"Absent increases in Medicaid/CHIP participation in the ten states that account for 61 percent of all eligible uninsured children, there would still be close to three million uninsured children nationally who are eligible for Medicaid/CHIP even if the remaining forty states were able to achieve participation rates close to 100 percent," the report said.
"Moreover, because California, Florida, and Texas together account for 1.8 million of the total eligible uninsured children, increasing participation in those three states will be critical to reaching the national goal," it added.
Support From Federal Government
In a commentary accompanying the report, Sebelius said the federal government "will provide support and technical assistance to build on efforts already under way in several states to streamline the enrollment process. We are also working with partners across the country to explore ways to expand the use of telephones, text messaging, and other technologies in outreach and enrollment."
Sebelius said the federal government also is working with states and community organizations to identify the most effective ways to reach out to families, and then enroll their children "where they live, learn, play, work, worship, and receive health care."
"We are striving to make enrollment assistance an ongoing and routine activity," she stated.
The Urban Institute study is available at http://content.healthaffairs.org/cgi/content/full/hlthaff.2010.0747v2
The commentary on the issue by Sebelius can be found at http://content.healthaffairs.org/cgi/content/full/hlthaff.2010.0852v1.
More information on Sebelius's "Connecting Kids to Coverage Challenge" program can be found at http://insurekidsnow.gov