Latest Drugwonks' Blog
During my tenure at the FDA I served on the agency’s first Counterfeit Drugs Taskforce. Alas, one of the items in our draft report – that criminal penalties for counterfeiting be significantly enhanced – didn’t make it into the final recommendations since it was seen as exceeding the agency’s mandate (and stepping on toes at the Department of Justice).
Well – better late than never. A new bipartisan (and bicameral) effort has been introduced to stiffen the penalties counterfeiters will face for putting illegal and unsafe medicines into the medicine chest of unsuspecting Americans.
The Counterfeit Drug Penalty Enhancement Act will increase penalties for the trafficking of counterfeit drugs to reflect the severity of the crime and the harm to the public. While it is currently illegal to introduce counterfeit drugs into interstate commerce, the penalties are no different than those for the trafficking of other products, such as electronics or clothing. The Counterfeit Drug Penalty Enhancement Act will target violators that knowingly manufacture, sell or traffic counterfeit medicines to the USA.
On the Senate side the bill is sponsored by, Patrick Leahy (D, VT), Chuck Grassley (R, IA), Michael Bennet (D, CO), and Richard Blumenthal (D, CT) and on the House side by Patrick Meehan (R, PA) and Linda Sanchez (D, CA).
Senator Leahy: “While the manufacture and sale of any counterfeit product is a serious crime, counterfeit medication poses a grave danger to public health that warrants a harsher punishment. This legislation will raise those penalties to a level that meets the severity of the offense. Deterring this epidemic problem is a bipartisan effort.”
Senator Grassley: “Counterfeit medicines are some of the most profitable commodities for criminal organizations. Purchases of counterfeit drugs by unsuspecting customers are growing at alarming rates, especially over the internet.” These drugs present a serious threat to the health and safety of people around the world. It’s important we address this threat by imposing harsher penalties on criminals who counterfeit these medicines.”
It’s about time.
Alas Avastin.
Rather than rehashing the debate, let’s just say (1) this decision wasn’t a surprise and (2) it’s a missed opportunity for advancing regulatory science.
Regardless of where you stand on Avastin for HER2-negative metastatic breast cancer – this was a “teaching moment” for the FDA. And the agency missed it.
Specifically, it was an opportunity for the FDA to talk about the future of molecular diagnostics and how it wants to be a partner with industry in their development. Peggy & Co. should have taken the opportunity to go beyond communicating a specific regulatory decision and seized a leadership position on a crucial healthcare policy issue. This is even more disappointing considering the high profile the agency has given recently (and appropriately so) to its Advancing Regulatory Science Initiative (ARSI).
Alas not.
When politics trumps the public health bad things happen. The current conversation surrounding the reauthorization of the Prescription Drug User Fee Act (PDUFA) must focus on (among other things) the First Principle of Predictability as well as ensuring that the FDA can fulfill its role as an important ally in advancing healthcare in America.
Please join the Center for Medicine in the Public Interest (www.cmpi.org) and some of the nation’s top experts in PDUFA and FDA reform for an interactive panel discussion of “Defining the Future of the FDA: PDUFA V and Beyond.”
RSVP to Mario Coluccio: mcoluccio@cmpi.org
DELI LUNCH TO BE SERVED
DATE: Tuesday, November 29th
TIME: 12:00 – 1:30PM
LOCATION: RM. 2168 (Gold Room) Rayburn House Office Building
Peter J. Pitts (Moderator), Former FDA Associate Commissioner, President of the Center for Medicine in the Public Interest
The Honorable Michael C. Burgess, M.D., Vice-Chairman, Subcommittee on Health, U.S. House of Representatives
Vincent J. Ventimiglia, Jr, Former Assistant Secretary for Legislation at the US Department of Health and Human Services, Senior Vice President in the Health and Life Sciences Practice at B&D Consulting, a division of Baker & Daniels LLP.
Paul T. Kim, Former Deputy Staff Director for health policy for Senator Edward M. Kennedy, Partner at Foley Hoag LLP in the Government Strategies practice.
Michele J. Orza, Former Assistant Director of the Health Care Team at the Government Accountability Office, Principal Policy Analyst at the National Health Policy Forum.
Tim Franson, Former Vice President, Global Regulatory Affairs, Eli Lilly & Co., President, USP Convention, Senior Vice President, Health and Life Sciences Sector, B&D Consulting.
RSVP to Mario Coluccio: mcoluccio@cmpi.org
- GRASP spokesman Evan Siegfried
This was in response to the Congresswoman’s comment about Gardasil earlier this week in Iowa, where she told a parent that her daughter shouldn’t “have to live with the ravages of this vaccine.”
Plan Would Delay Sales of Generic for Lipitor
By DUFF WILSON
"The biggest introduction of a generic drug in pharmaceutical history is being met with tough business strategies by Pfizer and pharmacy benefit companies, according to recent letters to pharmacists.
Many drugstores are being asked to block prescriptions for a generic version of Pfizer’s Lipitor starting Dec. 1, when the company loses its patent for the blockbuster cholesterol drug and generic competition begins.
Medco Health Solutions, among the nation’s largest pharmacy benefit managers, is one of the companies issuing instructions, seeking to have pharmacists keep filling prescriptions with the more expensive Lipitor for six months."
http://www.nytimes.com/2011/11/12/health/plan-would-delay-sales-of-generic-for-lipitor.html?_r=2
Except that it won't be more expensive to consumers...
"Pfizer has agreed to large discounts for benefit managers that block the use of generic versions of Lipitor, according to a letter from Catalyst Rx, a benefit manager for 18 million people in the United States. The letters have not previously been made public.
A pharmacy group and an independent expert say the tactic will benefit Pfizer and benefit managers at the expense of employers and taxpayers, who may end up paying more than they should for the drug.
Pharmacy benefit managers are middlemen between drug companies (the sellers) and insurers and employers that sponsor insurance plans (the buyers). "
Let's presume Wilson's unsupported assertion that employers and taxpayers will pay more is correct even though it isn't since PBMs benefit whether the price drops due to discounts or generic drug introduction. Should patients who are on Lipitor be forced to instantly switch to a generic version? Did Duff consider the impact of drug switching to save money in the short term on the ability to reach optimal lipid levels?
No. And he should have. An across the board switch can and does affect compliance. And in the short term at least a percentage of patients (of all ages) saw their bad cholesterol levels increase. Switching from high-efficacy lipid-lowering therapies to simvastatin and low-density lipoprotein cholesterol goal attainment in coronary heart disease/coronary heart disease-equivalent patients. Tunceli K, Sajjan SG, Ramey DR, Neff DR, Tershakovec AM, Hu XH, Tomassini JE, Foody JM. J Clin Lipidol. 2010 Nov-Dec;4(6):491-500
How many strokes and heart attacks occured as a result? Duff doesn't care.
I am not making a case against using generic drugs or even switching. Rather, I am asking why the NY Times and every other major media outlet never considers the impact on price-driven changes on the total health or cost of care. Switching has to be done carefully and has to be explained to patients that equivalent generic drugs are generally as safe and as effective as the innovator product. So a six month transition process, paid for by Pfizer and PBMs is not sticking it the taxpayer. It could be smart and patient-centered medicine.
Does Duff understand that?
In the case of the Commerce Clause and whether the government can compel people to purchase health insurance the Court is, following the reasoning of Judge Silberman, The Court will look at " four factors in determining whether legislation represents a valid effort to use the Commerce Clause power to regulate activities that substantially affect interstate commerce. I am paraphrasing from the Supreme Court decision to invalidate the Gun-Free School Zones Act of 1990 on the grounds is exceeded the authority of Congress to regulate under the Commerce Clause:
Whether the activity was non-economic as opposed to economic activity; previous cases involved economic activity.
Whether the purchase of insurance is an interstate commerce activity
Whether there had been Congressional findings of an economic link between not purchasing insurance, the economy and/health care costs at any point in time
Whether there is a link between regulated activity or inactivity and interstate commerce. http://en.wikipedia.org/wiki/United_States_v._Lopez
The third factor is the one that Silberman focused on. And like other judges who did so they bought the argument that without a mandate people who didn't have insurance would add costs to the system at some point and therefore not buying coverage is, broadly defined, an economy activity. However, one aspect of the Lopez case not always considered in current discussions. The Court of Appeals that ruled the Gun Free Act unconstitutional found the findings and evidence presented before Congress to justify the passage of the Act pursuant to the federal Commerce Clause power was simply insufficient to uphold the Act. http://en.wikipedia.org/wiki/United_States_v._Lopez#cite_note-9
I don't know if the states bringing suit against the federal government have raised or will raise this argument. I don't know if doing so is a plausible legal strategy. But it would seem pretty easy to poke holes in the claim that the lack of a mandate is responsible for rising health care costs and to argue that the findings and evidence presented by Congress are not enough to support the health care law.
It's probably a point worth pursuing for the following reason: I still believe that whatever the Court decides it won't be to the advantage of the proponents of the law and President Obama in particular. If the Court overturns the mandate the administration has made it clear that the rest of the expansion of government power can go on, as well it can. And if the Court upholds the law, it will re-ignite resentment and then some. Whatever happens, Obamacare will become an important campaign issue, as will it's repeal or wholesale revision. That is as it should be.
The Supreme Court said on Monday it would consider the challenge to last year's health care reform law, setting up a major ruling on the Obama administration's signature legislative achievement just months before the presidential election.
The case is likely to be heard in March, meaning that a final decision is likely at the end of the Court’s term, in June.
Apparently in recognition of the complexity of the issues presented by the cases, the Court has asked for an unusual amount of time for oral arguments. The order said the court would listen to five and a half hours of arguments—a rare departure from its usual practice of allocating an hour to hear a case.
The Court has asked lawyers to answer four legal questions about the law in their briefs, signaling that it will issue rulings on each of them.
Read more here.
The Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) proposed by Senator Kay Hagen (D,NC) would create two new FDA approval pathways. Drugs would be eligible for "progressive" or "exceptional" approval if they provide meaningful advances in the treatment of an unmet serious or life threatening condition. FDA could also approve drugs based on approval in the EU as well as in Australia, Canada and some other countries.
TREAT would permit progressive approval based on data "reasonably likely" to predict clinical benefit, the standard currently used for accelerated approval. Unlike accelerated approval, drugs could receive progressive approval without data from a surrogate endpoint. Exceptional approval could be granted when the data necessary to satisfy the standard for approval "cannot ethically, feasibly or practicably be generated." would also relax conflict of interest restrictions for advisory committee members, create a fixed term for the FDA commissioner, and revise FDA's mission statement to emphasize the promotion of biomedical innovation.
The draft bill can be found here.
http://washingtonexaminer.com/opinion/columnists/2011/11/david-salzmans-valiant-fight-what-truly-matters
David Salzman's valiant fight for what truly matters
By: Diana Furchtgott-Roth | 11/10/11 8:05 PM
It was December 2006, just before Christmas, when my friend David Salzman called. "I have bile duct cancer, and they've given me only three months to live."
That was almost five years ago. At 1 am on Saturday morning, David, age 53, a Maryland entrepreneur, succumbed to an infection, dying at Johns Hopkins Hospital in Baltimore, with his mother, Nancy Salzman, next to him.
He was one of the longest-surviving patients with bile duct cancer. As well as his mother, he leaves his wife, Beth Kevles; two children, Michael, 16, and Joel, 14; and his brothers, Andy and Jimmy.
For David, our health insurance system worked. As an entrepreneur, he had small-business insurance through Blue Cross Blue Shield. It didn't drop him and never questioned his care. David had only praise for Blue Cross.
I met David in Washington, D.C., in 1986. With two degrees in physics, a B.S. from Yale and a Ph.D, from the University of Chicago, he could have taken the usual academic route. Instead, he founded startups to develop new products.
One of his first companies was Polychip, where he pioneered proximity chip-to-chip communication, which dramatically increases the data rate between chips by stacking them on top of each other.
David sold that patent to Sun Microsystems, later bought by Oracle, which now has a government contract using the technology to develop a new generation of supercomputers.
Another of his companies, LightSpin Technologies, uses new ways to manipulate, detect, and generate light. When David died, he was developing ways to use light waves to find land mines. He considered this vital because of the danger posed by hidden mines.
One of his partners, Eric Harmon, told me, "You shake the ground with a loud noise, and then use the pattern of the sound waves to find the land mines."
Right until his death, David was active in community meetings about the new Montgomery County rail line, the Purple Line. He was intensely concerned with the way politics were overcoming science, and showed how studies justifying the project were artificially inflating ridership and energy savings and minimizing the noise levels.
David was more than just a scientist, he was a modern Renaissance man, able to enjoy literature, opera, and politics with equal knowledge and gusto. That's why my husband and I asked him to be the godfather to our third son, Godfrey, hoping a little magic would rub off.
"There wasn't anything that could be learned that David didn't want to learn," his mother told me on Wednesday.
This extended to his cancer treatments. David's college buddy, Phil Schiff, organized a team of friends to drive David to Hopkins for his weekly treatments so that Beth could spend more time with the boys. I was honored to be on the team.
At the hospital, David would go over the printouts of the blood tests, questioning the nurses and technicians. He chose the most aggressive treatments possible, overcoming pain and side effects, anything to have more time with his family.
Thoughts of his family spurred him on. David kept going by trying to survive until specific events such as Michael's bar mitzvah, Joel's bar mitzvah, and then, the final goal, Michael's 16th birthday on Sept. 23.
Beth told me on Thursday, "David did not want to be remembered for his cancer. Cancer was what he had, not what he was." On the drives to Hopkins we'd talk not about cancer treatments, but about how our various children were doing in school and what they would do over the summer.
Because, in the end, that's what matters.
The Digital Health Council (DHC) was created to serve as the collective public voice and provide a national public forum for the discussion of current and future issues relevant to digital and electronic marketing of healthcare products and services. I am honored to serve on the Council’s advisory board.
On October 13, 2011 at the Marketing to the Digital Consumer conference in Fairfield, NJ (hosted by DTC Perspectives), I participated on a panel with some of my fellow DHC advisory board members. My fellow panelists were:
Mark Bard, Co-founder of the Digital Health Coalition
Joan Mikardos, Senior Director, Digital Center of Excellence, Sanofi
Jeremy Shane, President and Chief Operating Officer, HealthCentral
Jay Goldman, VP Strategy, Klick
Gautam Gulati, Chief Medical Officer, Physicians Interactive Holdings
My opening comments commenced as follows:
In my opinion, social media must be viewed primarily as a way to advance public education, public health, adherence, compliance – all the things we say are really important – but always come second to selling product. We’re not going to advance the use of social media as long as we’re stuck in “sell” mode. When we move towards advancing the public health we begin to revive the mission of the pharmaceutical industry.
A transcribed version of the panel discussion has been created as a white paper and can be found here. No punches were pulled.
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.
