Latest Drugwonks' Blog
Congrats to former CDER Director, Acting Surgeon General and all-around decent guy Steve Galson on his appointment as Global Regulatory VP for Amgen.
In August 2009, a study (conducted by research firms LegitScript.com and KnujOn.com) found that over 80% of on-line advertisements for Internet pharmacies accepted by the search engine Yahoo were in violation of US federal and state laws. The researchers were able to buy prescription drugs without a prescription from Yahoo Internet pharmacy advertisements, and in one case the drugs were imported from India, which is prohibited by US law, says the survey, which was.”
In September 2010, Google filed a federal lawsuit seeking to block groups it called "rogue online pharmacies" from advertising on its search engine and websites.
According to the Wall Street Journal, “The move comes as Internet companies continue efforts to prevent fraudsters from preying on their customers, potentially keeping them from doing business with legitimate online operators.”
"Rogue pharmacies are bad for our users, for legitimate online pharmacies and for the entire e-commerce industry—so we are going to keep investing time and money to stop these kinds of harmful practices," said Google lawyer Michael Zwibelman.
That’s all well and good—but it’s not new. In December 2003, Google said they would stop accepting advertising from unlicensed pharmacies that have used the Internet to sell millions of doses of narcotics and prescription drugs without medical supervision.
As the Washington Post reported at the time, “Illegal Internet pharmacies have become a virtually unregulated pipeline for highly addictive painkillers, tranquilizers and anti-depressants that have resulted in overdoses and deaths.”
Back in 2003, the FDA was aware of the problem and trying to work with the search engine community. As the Post reported, "We're literally placing calls to the search engines trying to get a meeting going," said Peter J. Pitts, the FDA's associate commissioner for external affairs. "You can't blame them for accepting commerce. But they really haven't understood the consequences."
Plus ça change …
Much discussion at the Business of Biosimilars conference today about the evils of evergreening. Purity, potency and safety? Feh.
Other topics of heated debate centered around whether or not “biobetters” would always precede biosimilars (most thought so) and whether or not that was a good thing. (Different points of view depending on whether you’re looking at it from a developer, payer or provider standpoint. (Hint – there weren’t any providers in the room.)
And there seemed to be general consensus that, with a clear FDA pathway still off in the future, BLAs are the way to go. Hence a redefinition of BLA as “Beat Legislative Ambiguity.” No aBLA biosimilar.
Badges? We don’t need no stinking badges.
Two interesting comments from Leigh Purvis (Senior Strategic Policy Advisor, AARP). The first was that the folks at AARP are concerned that “biologics will soon be used to treat paper cuts.” (Nice to reconfirm where they stand on the issue.) And the second that, while it’s important to educate AARP members about both generics and biosimilars –“there isn’t any money available in the budget.”
Draw your own conclusions.
A funny thing happened on my way to the Business of Biosimilars conference in Boston -- a draft document about a two-day FDA public hearing on FOBs began making the rounds.
According to the draft, the hearing will take place on November 2nd and 3rd and, potential changes notwithstanding, provides insight into the future of FDA-regulated biosimilars.
"The purpose of this public hearing," the document states, "is to create a forum for interested stakeholders to provide input regarding the agency’s implementation of the statute concerning the following issues, among others:
* Scientific and technical factors related to a determination of biosimilarity or interchangeability;
* The type of information that may be used to support a determination of biosimilarity or interchangeability;
* Development of a framework for optimal pharmacovigilance for biosimilar and interchangeable biological products;
* Scope of the revised definition of a “biological product”;
* Priorities for guidance development;
* Scientific and technical factors related to reference product exclusivity;
* Scientific and technical factors that may inform the agency’s interpretation of “product class” as it relates to available regulatory pathways for certain protein products during the 10-year transition period following enactment of the BPCI Act; and
* The establishment of a user fee program for biosimilar and interchangeable biological products."
An ambitious agenda for two-weeks or two months – let alone two days. But, you’ve got to start somewhere.
And none too soon if the frustration, confusion, angst and agita (pardon the mixed ethnography) at the Boston confab is any indication of the larger issues in play.
And from the “Use That Gavel While You’ve Got It” department, draft legislation unveiled Monday (courtesy of Representatives Henry Waxman, Frank Pallone, John Dingell, and Bart Stupak) aimed at boosting the FDA's authority to monitor the sale of prescription drugs, which increasingly occurs on a global scale.
"Americans have been alarmed in recent years over some very concerning issues related to the quality and safety of certain drug products. We know we need to address this. The only question now is how," Dingell said in a statement.
The draft legislation would require "parity" between inspections of foreign and domestic drug manufacturing plants. Now, overseas production sites are inspected much less often than U.S.-based facilities. It also would require that manufacturers "ensure the safety of their supply chain" and would give the FDA power to mandate recalls of unsafe medicines.
Dingell stated, "Americans have been alarmed in recent years over some very concerning issues related to the quality and safety of certain drug products. We know we need to address this. The only question now is how."
“How,” it seems, is the order of the day.
This goal, though not fleshed out in a detailed legislative proposal, is much more than a campaign slogan. That conclusion emerged from interviews with a wide range of Republican lawmakers, who said they were determined to chip away at the law if they could not dismantle it.
In these bad times, bio drugs create jobs
There are some silver linings in these dark economic clouds. Chief among them is the resilience of the American biopharmaceutical sector. Our leaders should work to build on its economic success.
Through 2008, during the worst recession in more than a generation, the biopharmaceutical sector grew by 1.4 percent. At the same time, total private-sector employment went in the opposite direction, declining 0.7 percent. Without the robust growth of biopharmaceutical companies, the recession would’ve been even worse.
America dominates biopharma. In 2007, more than 2,700 drugs were under development in the U.S. — compared to just 1,700 in the rest of the world.
From 1996 to 2006, the number of domestic jobs in the industry exploded, growing at twice the rate of job creation elsewhere in the economy. Biopharma employs almost 700,000 people and supports 3.2 million American jobs.
These are good-paying jobs, too. The average salary in the biopharmaceutical sector was $77,595 in 2008 — $32,000 more than the average private-sector job.
But the biopharmaceutical sector does more than foster economic growth — its research also saves lives.
Antiretroviral treatments have cut AIDS deaths by 70 percent. Innovative drugs are largely responsible for cutting cancer death rates in half. One Columbia University study found that between 1991 and 2004, the average American lifespan increased by nearly 2 1/2 years. The researchers attributed this staggering achievement to new drugs and better medical imaging technology.
But American dominance of this sector in the future isn’t a certainty. European and Asian companies are fighting harder and harder for a larger piece of the biopharma pie.
So how do we make sure that America remains at the top?
First, the U.S. must remain an attractive place to do business. Biopharma is a very dynamic industry. Scrappy start-ups compete head to head with some of the biggest companies in the world. Excessive taxes and an onerous regulatory environment will discourage new businesses from sprouting up, and will prompt more established actors to seek friendlier climes abroad.
Second, the U.S. must resist the temptation to forcibly limit the price of drugs. Pharmaceuticals are a high-risk, high-reward business. The average drug costs more than $1 billion to develop. For every 5,000 to 10,000 compounds that enter testing, only one will get FDA approval and make it to market.
If government price controls prevent companies from recouping the billions they pour into research and development, then investors will refuse to fund the next round of innovative research.
Finally, America’s leaders must work to improve the American educational system so that we can produce the bright young people that medical research requires.
American students rank 21st in science and 25th in math when compared to students from 30 other countries. Our lack of science and math aptitude threatens to imperil our standing as a global leader in innovation.
President Barack Obama has spoken forcefully about closing this gap, and his administration’s “Educate to Innovate” program has committed $260 million to improving math and science education. This is a good start, but more needs to be done.
In this trying economy, America’s biopharmaceutical sector provides a reason for optimism. Our leaders must make sure that the industry can continue to grow and breathe new life into the economy.
From today's edition of Reuters' "Great Debate" series:
Let cancer patients have this pill
By: Peter J. Pitts
One more day — or week, or month, or perhaps even a year. It may not seem like much time, but patients with incurable cancer know better. For Christi Turnage of Mississippi, who lives with stage IV breast cancer, it means seeing her daughter start kindergarten, celebrating her 27th wedding anniversary, and watching her sons graduate from college.
Her family and her oncologist credit her quality of life for the past two years to the drug Avastin, a biologic that combats cancer by cutting off the blood supply to tumors. But advanced breast cancer patients like Turnage have been forced to spend precious time battling something else: the possibility that federal regulators will vote today to remove approval of Avastin for their treatment.
If officials with the U.S. Food and Drug Administration are wise, they will overrule the agency’s cancer-drug advisory panel, which voted 12-to-1 last month to recommend denying a valuable clinical option to advanced breast cancer patients. According to the Department of Health and Human Services, an estimated 40,000 women die from breast cancer each year.
The panel concluded that the costly drug doesn’t eke out enough extra lifetime among breast cancer patients to justify its use and risks. This ignores all the “super responders” — the patients who reap significant benefits from Avastin. Scientists have no way of identifying these people in advance, and they could be devastated if they are denied the medicine.
“This is not a worthless drug by any means,” Eric Winer, director of the Breast Oncology Center at the Dana-Farber Cancer Institute in Boston. “There is almost certainly a group of women who get a big benefit.”
Indeed, the Susan G. Komen for the Cure and Ovarian Cancer National Alliance – recently sent a joint letter to the FDA urging the government to keep it as a choice best made by a woman and her doctor.
The groups also warned that if the FDA de-lists Avastin for breast cancer, it would only discourage future drug development.
Two years ago, the FDA fast-tracked approval of Avastin for metastatic breast cancer two years ago, and since then it has been prescribed to about 17,500 women a year with the disease. The drug, which earned FDA approval for the treatment of colon, lung, kidney and brain cancer, is the world’s best-selling cancer drug.
A clinical trial that took place from December 2001 and May 2004 found that Avastin boosted the amount of time that breast cancer patients lived without the disease spreading or worsening. The drug in combination with chemotherapy delayed tumor growth for about 11 months, which was more than five months longer than chemo alone. Follow-up studies indicated a less robust response, yet still found an average delay in tumor growth to between one and three months.
But even if Avastin does not, “on average,” extend life for breast cancer patients, that “average” is composed of patients who respond in dramatically different ways –including some like Christi Turnage who gain years.
Another is retired California art teacher Patricia Howard, who reports that infusions of Avastin every three weeks over the past two years have shrunk tumors in the lining of her lung and eliminated fluid that hampered her breathing. Now she enjoys shopping and golf, and describes her life as “beyond fabulous.”
Serving as a patient representative at the FDA’s last session, Howard recalled, “One doctor got up during the meeting and said ‘This drug gets women only to first base and we want a home run.’ I felt like jumping up and saying I don’t mind just being in the ballgame.”
If the FDA does remove approval of Avastin for breast cancer, doctors conceivably could write prescriptions for it anyway, going “off label.” But it’s likely that Medicare and private insurers would not cover the cost of what is one of the world’s most expensive drugs. Patients could continue Avastin only if they could afford $8,000 a month out of pocket.
Avastin is a better alternative than the status quo for breast cancer patients, and can be truly transformative for some. No wonder Avastin-users are desperately writing letters, circulating petitions and, like Turnage’s 19-year-old son Josh, posting videos on YouTube pleading their case.
Avastin is their last hope. The FDA should make sure it is not their lost hope.
(Reuters) - A new process to review medical products at the U.S. Food and Drug Administration in tandem with the nation's Medicare insurance program could help speed up coverage decisions, the FDA said in announcing the move on Thursday.
Under the proposal, the FDA would review and make approval decisions alongside the Centers for Medicare and Medicaid Services, which decides whether and how to pay for new medical products for its elderly and disabled patients once they are approved for the U.S. market.
To start, the agencies proposed a pilot project for devices after both FDA and CMS had time to review public comments on the proposal.
More than 45 million people are covered under the Medicare program. Private insurers often weigh CMS's coverage decisions when setting their own reimbursement policies, and a decision by Medicare to cover a new product can speed its adoption in the wider marketplace.
This litte group of elites guessed wrong. Poll and after poll shows that not is Obamacare wildly unpopular but it remains a principal reason for voters to toss out Democrats in November.
Yet, the elites still insist that the law is popular:
"A new CBS/New York Times poll has found that 49 percent of Americans oppose the health care law, compared with just 37 percent who support it.
ObamaCare booster Jonathan Cohn, while acknowledging that recent polls have been discouraging, sees some silver lining in the CBS/NYT poll. He notes that "While 40 percent of respondents said they supported repealing the Affordable Care Act, more than half changed their minds (leaving just 19 percent in favor of repeal) when pollsters mentioned that it'd mean letting insurance companies exclude people with pre-existing conditions."
What a hypocrite. As Phil Klein of the American Spectator points out:
"Yet this is the same argument that proponents of the legislation have used all along to explain poor poll results -- that it's more popular when you ask separately about its component parts. The problem is that the popular parts are linked to other less popular parts to make up the whole."
spectator.org/blog/2010/09/16/opposition-to-obamacare-rises
Moreover, Cohn and others have always insisted that you can't provide such exemptions without forcing everyone to buy into government approved plans and using price controls and rationing to control use of services. You can't have it both ways: point to support of changes people are in favor of yet insist that the entire law in its current form must be implemented. If pollsters mentioned other aspects of the bill -- as an earlier CMPI poll showed -- support evaporates.
The fact is, repealing the worst features of Obamacare and replacing it with something that gives people coverage, choice and control over health care decisions is something a vast majority of Americans favor.
pajamasmedia.com/files/2010/03/CMPIA.PJM-raw-data.pdf
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.
