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In a speech at the annual meeting of the National Academy of Sciences, President Obama said that scientific research mustn’t ‘fall victim to political maneuvers or agendas that in some ways would impact on the integrity of the scientific process."
Except, of course, when such interference forwards his agenda.
‘Nuff said.Read More & Comment...
There should be one rule for reimbursement: If a treatment is targeted and works best in a particularly patient, it should be used and paid for. Indeed, many new medicines actually save health plans and hospitals money, especially if they target a particular mutation or disease mechanism in a smaller group of patients. Why should we pay more money for medicines that are more effective and more valuable? We shouldn't. And it speaks to the issue of patients being exposed to higher copays for cancer treatments that, while expensive, a less costly than the types of care they replace. So does The Cancer Drug Coverage Parity Act, H.R. 1801 a new congressional proposal to end discrimination against patients who opt for an oral form of therapy that works best for them. Sponsored by Congressman Brian Higgins (D-NY) the legislation would require insurance companies to cover patient-administered and physician-administered anticancer drugs at the same cost to patients.
This is a piece of legislation that ensures regulation keeps up with medical innovation. Let's hope it passes and is signed into law as quickly as possible.
Read More & Comment...
A new op-ed appearing in The Washington Times. Please excuse the headline – I didn’t write that. I support quality, legal generic medicines. I do not support the blatant disregard of intellectual property – or the dangerous and deleterious consequences such behavior has on the public heath.
When generics win, patients lose
Failure to protect patents stifles drug profits and innovation
A court ruling in India could stifle medical innovation worldwide.
On April 1, the Indian Supreme Court rejected a patent request for a version of the cancer treatment Gleevec, citing a 2005 law intended to thwart companies from obtaining fresh patents for minor changes to a medicine. The law itself, and the court’s decision, is a boon to India’s prosperous $26 billion generic-drug industry. The blatant failure to protect the intellectual property of biopharmaceutical innovators, though, will have terrible consequences for drug development and patient health.
Bringing a medicine to market is a long and complicated process. According to the Tufts Center for the Study of Drug Development, it takes 10 to 15 years for an experimental drug to reach the market. Including the costs of failures, each medicine costs an average $1.2 billion to develop.
Generic-drug manufacturers don’t have these massive upfront development costs. They don’t need to worry about investing in research and development for revenue. They piggyback on the research and investments of the pharmaceutical companies that create the brand names. India’s generic-drug manufacturers are among the largest in the world.
Gleevec, a cancer treatment from Swiss-based pharmaceutical company Novartis, was a major pharmaceutical breakthrough for cancer patients around the world. A patient advocacy group in Mumbai lauds it as “the only lifesaving drug” for chronic myeloid leukemia.
Gleevec is patented in nearly 40 countries, including China and Russia. Because the drug was introduced in India before the country enacted its first patent law in 2005, the treatment has gone unpatented.
When Novartis applied for a patent on a beta crystal reformulation of Gleevec, an important improvement that makes the medicine more stable, Indian regulators denied it, saying the difference between the two versions was too small. Novartis filed a petition with the Indian Supreme Court in 2009 to challenge the denial.
Novartis went to court not only to defend its patent interests for Gleevec, but also to defend the larger principle that intellectual-property protections are essential to innovation and the advances of medical science. The Indian Supreme Court’s decision essentially tells innovators not to bother improving on their products because they will reap no reward for doing so.
Some are trumpeting the case as a victory for patient access. The generic version of Gleevec costs about $175 per month per patient, compared with $2,600 for the brand-name drug.
The raw price comparison misses the point. Ninety-five percent of the 16,000 Indian patients prescribed Gleevec receive the medication at no charge through a program Novartis has established to ensure that poor, uninsured patients get the medications they need regardless of ability to pay. The other 5 percent are reimbursed or insured or are enrolled in a generous co-pay program.
Novartis has provided $1.7 billion worth of Gleevec to Indian cancer patients since 2002 and donated $2 billion worth of medicines to more than 100 million patients worldwide in 2012 alone.
Price isn’t the problem, and patents don’t prevent access in developing countries. In fact, few of the approximately 400 drugs on the World Health Organization’s model essential drug list have ever been patented in the world’s poorest countries.
Patent protection does foster continued progress. Sometimes progress comes in the form of a big breakthrough, but sometimes it’s just a matter of an incremental advance. Either way, the work behind new medicines should be protected.
The Indian Supreme Court’s ruling is a blow to global public health. India’s generic-drug industry will profit, but patients will suffer the consequences.
Peter J. Pitts, a former Food and Drug Administration associate commissioner, is president of the Center for Medicine in the Public Interest.Read More & Comment...
It is with mixed emotions that I write to inform you of the upcoming departure of Deborah M. Autor, Deputy Commissioner for Global Regulatory Operations and Policy (GO), after 18 years of dedicated federal government service, including 11 years spent here at FDA.
Deb has overseen various critical programs within the Agency including, most recently, the GO Directorate. In that role, Deb has led the implementation of FDA’s strategy for addressing the challenges of globalization and import safety, including the paradigm shift that FDA must make to meet the challenges of globalization today and in the future through global coalitions, global data systems, advanced risk analytics, and leveraging of the efforts of public and private third parties. Deb has outlined a strong vision for GO that focuses on being data-driven, strategic, and risk-based, moving towards a stronger global product safety net to advance and protect public health. Prior to assuming the role of Deputy Commissioner, Deb worked in several critical positions within the Office of Compliance in FDA’s Center for Drug Evaluation and Research (CDER), including for five years as its Director.
Deb is leaving the Agency to take the position of Senior Vice President, Strategic Global Quality and Regulatory Policy at Mylan, Inc. Please join me in wishing Deb all the best as she and her family relocate to the Pittsburgh area and embark on this new endeavor. While I am sad to see Deb go, I am happy that she has found this terrific opportunity. Deb has demonstrated great leadership, creativity, and passion for public health throughout her FDA career, and we will miss her. Deb’s last day at FDA will be June 1, 2013.
I am pleased to announce that John M. Taylor, III, currently the Counselor to the Commissioner, has graciously agreed to serve as Acting Deputy Commissioner for Global Regulatory Operations and Policy in the short term starting May 18 as we look for a permanent replacement for Deb.
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Read More & Comment...
In recent weeks, there have been increasing expressions of concern from surprising quarters about the implementation of ObamaCare. Montana Sen. Max Baucus, a Democrat, called it a "train wreck." A Democratic colleague, West Virginia's Sen. Jay Rockefeller, described the massive Affordable Care Act as "beyond comprehension." Henry Chao, the government's chief technical officer in charge of putting in place the insurance exchanges mandated by the law, was quoted in the Congressional Quarterly as saying "I'm pretty nervous . . . Let's just make sure it's not a third-world experience."
These individuals are worried for good reason. The unpopular health-care law's rollout is going to be rough. It will also administer several price (and other) shocks to tens of millions of Americans.
Read the full piece here.
Read More & Comment...
According to incoming PhRMA Chairman Robert Hugin (chairman and CEO of Celgene), the advocacy group’s agenda in the coming year will target policies that “most directly affect innovation and patient access to medicines.”
Starting with Medicare, PhRMA will focus the conversation on why policies that seek to control costs by targeting drug spending will hurt patients. Hugin: “We have to have a good defense; we have to play this part of the game.”
In short, it falls to PhRMA to lead the fight for “sustainable innovation.”
Hugin highlights two main areas of concern related to Medicare. First, he said. “We have to protect Medicare Part D. It is the role model for market-based solutions.” Next he pointed to an increasing concern in industry with retaining adequate reimbursement for drugs provided under Medicare Part B (generall administered by physicians). The growth in very high-priced specialty drugs, such as targeted cancer therapies, is contributing to a new focus among payers on containing Part B drug costs.
Hugin: “We have to defend Part B. We have to ensure that reimbursement rates don’t change so significantly that access to patients for those types of medicines, physician-administered, are restricted, and [that] leads patients back to hospitals and higher [overall medical] costs.”
Among the other advocacy priorities, Hugin points to the need to “ensure the 340B program is administered effectively and appropriately.”
According to Hugin, PhRMA will also focus on making sure the 12-year marketing exclusivity available to biologics under the law for biosimilars “is maintained, not just in this country, but in all the trade agreements that our country negotiates.” He also said that industry must “assertively defend intellectual property all across the globe.”
As per state exchanges and other codicils of the Affordable Care Act, Hugin stressed that, “We have to make sure that we support initiatives that … do not restrict access to important innovative medicines for patients all across this country.” And he vowed to “continue the fight” to repeal the Independent Payment Advisory Board, which was established by the ACA.
The biopharmaceutical industry, per Chairman Bob, must continue to support FDA and ensure “proper funding” of drug review programs “so that we have a 21st century regulatory science system that allows us, in the most cost-effective and rapid way, to bring new therapies to patients.” He commented that the trade association’s experience in negotiating the most recent prescription drug user fee act reauthorization bill, which was enacted last year with bipartisan support, was a “remarkably” positive one.
Nobody said it was going to be easy.
When it comes to biologics, "the product is the process." Since the finished product cannot be fully characterized in the laboratory, manufacturers must ensure product consistency, quality, and purity by ensuring that the manufacturing process remains substantially the same over time.
As we move (albeit cautiously) into the era of biosimilars, one of the hoped-for advances is in manufacturing. Saying that such technologies are complicated is an understatement.
To achieve real success towards “better, faster, cheaper,” it is in the best interests of the public health for process mavens to work closely with the FDA to determine how new technologies can be expeditiously incorporated into biologics manufacturing standards.
Perhaps its time for the time for the FDA to create an advisory committee on biologics manufacturing standards and practices.Read More & Comment...
From today’s edition of the South Florida Sun Sentinel
Low costs medicines could jeopardize patient health
In Florida's House and Senate, lawmakers are currently working on legislation that would enable patients to purchase lower-cost alternatives to some of today's most-advanced medicines.
Unfortunately, a recent amendment to the legislation undermines the physican-patient relationship. It's critical for lawmakers to revert to their original proposal.
The legislation under consideration deals with a new class of medicines known as "biologics."
Unlike conventional drugs, which are made using basic chemical reactions, biologics are actually grown using living organisms. So they're much more complex. Consequently, when the patent on a biologic expires, competitors aren't able to make exact copies. But they can come close — so imitation biologics are called "biosimilars" instead of "generics."
Under federal law, the Food and Drug Administration will soon begin approving biosimilars. But the agency doesn't plan to issue any product-specific guidance to physicians or pharmacists prior to approving these drugs. And, it's not within the FDA's jurisdiction to tell states how to address the substitution of interchangeable biosimilars at the pharmacy — that responsibility falls to the state.
When Florida lawmakers in both chambers started work on their bills, they were model pieces of legislation — striking a balance between ensuring patient safety, and creating open access for more affordable new treatments.
The original bills stipulated Florida pharmacists would only be allowed to substitute a biosimilar for its brand counterpart if the FDA had certified the medicine as interchangeable with the innovator biologic.
The human body is complicated, of course, so it's possible that some biosimilars — even those deemed interchangeable by the FDA — will not work properly for certain patients, and because of the interaction of these treatments with a patient's immune system serious consequences can result.
The original legislation also required pharmacists to notify patients if a substitution had been made. And, because adverse reactions may not manifest themselves immediately, the bill also asked pharmacists to maintain dispensing records for four years. In the event that a biologic or biosimilar does not provide the intended treatment outcome, such records will prove vital.
Finally, and most importantly, the bill required pharmacists to notify prescribing physicians within ten days if a substitution had been made. It's important to underscore that this notification is required after the patient has already received the biosimilar.
These are all commonsense ssafeguards. They ensure that patients can access these less expensive new modifications safely.
But over the past week, House and Senate lawmakers have stripped the physician notification from their bill. This doesn't make sense — it ignores the most fundamental aspect of protecting the patient by cutting doctors out of the loop.
This change undermines patient safety. Biologics are incredibly complex — on average, they contain 1,000 times the number of atoms found in conventional chemical drugs. Doctors, especially those treating patients with multiple chronic or autoimmune conditions, need to know when their patients walk away from the pharmacy counter with a different medicine than the one they prescribed.
This change also undercuts physician autonomy and ignores the importance of transparency. In order to effectively treat their patients and protect against unintended health effects, doctors have the right to know if a substitution is made.
In both the House and the Senate, the earlier draft of the bill puts patients first. As lawmakers finalize this measure, it's critical that they fulfill their responsibility to keep patients at the cent of this debate, and to make sure that the legislation passes with all protections intact.
Peter J. Pitts, a former FDA Associate Commissioner, is the president of the Center for Medicine in the Public Interest.
Read More & Comment...
FDA Cautions in Interpretation of Antimicrobial Resistance Data
Recently, the Environmental Working Group issued a report of its interpretation of the 2011 Retail Meat Annual Report of the National Antimicrobial Resistance Monitoring System (NARMS). While FDA is always concerned when we see antimicrobial resistance, we believe the EWG report oversimplifies the NARMS data and provides misleading conclusions. We do not believe that EWG fully considered important factors that put these results in context, including:
- whether the bacterium is a foodborne pathogen. The report highlights resistance to Enterococcus, but this is not considered a foodborne pathogen. Instead, we include it because its behavior is helpful in understanding how resistance occurs.
- which drug(s) the bacterium is naturally resistant to. For example, most Enterococcus faecalis is naturally resistant to the antibiotic class of lincosamides. Because we know and expect to see this resistance, we are not as concerned with resistance in this species the way we would be with resistance in true pathogens like Salmonella and Campylobacter.
- why NARMS includes certain drugs in its testing design. We include some antibiotics for epidemiology purposes-- to track the spread of certain bacteria or certain genes. But resistance to these antibiotics doesn’t reflect a danger to public health.
- whether the antibiotics that are commonly used to treat patients are still effective. NARMS data indicates that first-line treatments for all four bacteria that we track (Salmonella, Enterococcus, Escherichia coli and Campylobacter) are still effective.
- what the 2011 data indicate relative to similar data reported for prior years.
Additionally, we believe that it is inaccurate and alarmist to define bacteria resistant to one, or even a few, antimicrobials as “superbugs” if these same bacteria are still treatable by other commonly used antibiotics. This is especially misleading when speaking of bacteria that do not cause foodborne disease and have natural resistances, such as Enterococcus.
When taking such factors into account, FDA believes the notable findings in the 2011 NARMS Report include:
- In the critically important class of antimicrobials, the 2011 data showed no fluoroquinolone resistance in Salmonella from any source. This is the drug of choice for treating adults with Salmonella.
- Trimethoprim-sulfonamide is another drug used to treat Salmonella infections and resistance remains low (0% to 3.7%).
- Fluoroquinolone resistance in Campylobacter has stopped increasing and remained essentially unchanged since the FDA withdrew the use of this drug class in poultry in 2005.
- Macrolide antibiotic resistance in retail chicken isolates remains low, with 2011 results at 0.5% of Campylobacter jejuni and 4.3% of Campylobacter coli. The macrolide antibiotic erythromycin is the drug of choice for treating Campylobacter infections.
- Multidrug resistance is rare in Campylobacter. Only nine out of 634 Campylobacter isolates from poultry were resistant to 3 or more antimicrobial classes in 2011. However, gentamicin resistance in Campylobacter coli markedly increased from 0.7% in 2007 (when it first appeared in the NARMS retail meat report) to 18.1% in 2011. Gentamicin has been suggested as a possible second-line therapy for Campylobacter infections, although it is not commonly used.
- Resistance to third-generation cephalosporins, which are used to treat salmonellosis, has increased in Salmonella from chicken (10 to 33.5%) and turkey (8.1 to 22.4%) meats when comparing 2002 and 2011 percentages. FDA noted this development in previous years and has already taken action by prohibiting certain extra-label uses of cephalosporins in cows, pigs, chickens and turkeys, and is continuing to closely monitor resistance to these drugs.
Antimicrobial resistance is a serious and challenging issue. It is critically important that we continue our efforts to minimize antimicrobial resistance, including promoting appropriate and judicious use of antimicrobials in both humans and animals.Based on a thorough review of the available scientific information, FDA has created a strategy for the judicious use of medically important antimicrobials in food-producing animals that states their use should be limited to situations where the drugs are necessary for ensuring animal health, and done so under veterinary guidance. It is the non-judicious use – for growth promotion and feed efficiency – that is of particular concern to FDA. This collaborative strategy is intended to provide the quickest way to achieve the greatest degree of public health protection, but it does not prevent FDA from initiating regulatory action in the future, if the agency finds it necessary. FDA welcomes all contributions in helping to understand and address the challenge of antibiotic resistance. However, it is very important to look at the NARMS data in the proper context, with a good understanding of the microbiology, epidemiology and genetics of antibiotic-resistant foodborne pathogens and their clinical management. Read More & Comment...
This week, the Louisiana Legislature will begin debating legislation that would force Louisiana to expand Medicaid as part of President Obama's health care law. It's a bad move for Louisiana taxpayers. Here are seven reasons why we shouldn't expand Medicaid.
1. The expansion of Medicaid will move up to 171,000 Louisianians off of private insurance and stop another 77,000 people from going into private insurance. Combined, that would force about 248,000 people out of private coverage and put them into the Medicaid program. The actual uninsured population that should be focused on is about 214,000 people. Instead, President Obama's healthcare law would actually add double that number—over 450,000 people—to the Medicaid rolls.
2. President Obama's Medicaid expansion could cost taxpayers in Louisiana $1.7 billion over the first 10 years of implementation, and the cost will continue to rise. Additionally, the percentage of state funds spent on Medicaid has nearly doubled over the past 16 years and expanding the program could further threaten funding for higher education, transportation, and other critical services.
3. By expanding President Obama's healthcare law, 41 percent of Louisiana's population would be dumped into Medicaid. Soon there will be more people riding in the cart than people pulling the cart. The President is gradually turning the world's greatest health care system into the world's largest welfare system. The left has been very clear—their end goal here is to make all healthcare in America government health care.
Read the full column here.
Read More & Comment...
I'm with Kim. And it goes double with the waste of money and time most health care policy 'analysis' really is.
Take this recent report from the Bipartisan Policy Center :
"Authored by former Senate Majority Leaders Tom Daschle and Bill Frist, former Senate Budget Committee Chairman Pete Domenici, and former Congressional Budget Office Director Dr. Alice Rivlin, who co-chaired the effort, the report contains over 50 integrated recommendations aimed at improving the affordability of care for all Americans.
"The four of us came together to change the conversation around how to improve health care and constrain cost growth. What we learned is that, until better care is prioritized over more care, our nation will continue to face a problem with health-care costs. This report is the culmination of nearly a year of work, including stakeholder outreach, thorough research and substantive analytics to quantify the impact of our proposed policies," said the co-chairs in an op-ed in The Washington Post today."
It took four smart people a year (including stakeholder outreach!) and hundreds of thousands of dollars to figure that out?
I've started following Kim on Twitter. Her approach to health care policy is a lot more reliable than the recombination of policy platititudes and presumptions that characterize most health care policy analysis.
Read More & Comment...
Obama officials insist the ads won’t be political, but critics recall that just before the 2010 midterm election, HHS spent $3.2 million on “educational” TV ads praising Obamacare. The spots featured the late actor Andy Griffith, a favorite of seniors, who told his fellow retirees that “more good things are coming” from Medicare. But FactCheck, a nonpartisan project of the Annenberg Public Policy Center, noted that the ads made no mention of the dramatic cuts to 10 million Medicare Advantage recipients, who are likely to see their privately managed care scaled back. “The words in this ad ring hollow, and the promise that ‘benefits will remain the same’ is just as fictional as the town of Mayberry was when Griffith played the local sheriff,” FactCheck concluded in July 2010.
Read more here.
Read More & Comment...
The White House has given the FDA approval to ask doctors about the marketing practices of drug companies. The FDA's survey project, which is expected to cost as much as $365,000 over two years, will question physicians, nurse practitioners and physician assistants on their opinions about how drugs are promoted to consumers and healthcare professionals.
Stay tuned.Read More & Comment...
Far better it is to dare mighty things, to win glorious triumphs even though checkered by failure, than to rank with those poor spirits who neither enjoy nor suffer much because they live in the gray twilight that knows neither victory nor defeat. – Theodore Roosevelt
Gray twilight be damned!
According to Rick Pazdur, if all drugs cleared for accelerated approval succeed in their confirmatory studies, then the FDA is being overly conservative in its use of the expedited approval pathway.
At the American Association for Cancer Research annual meeting in Washington, D.C., the Office of Hematology and Oncology Products Director said that if none of the drugs receiving accelerated approval is ever withdrawn, then the agency is taking an overly conservative approach in its approval of products under the pathway. “If you are demonstrating the correct degree of regulatory flexibility, there are going to be successes and there are going to be failures … If there are no failures, you … are being over-regulatory and over-conservative.”
Dr. Pazdur made his remarks while moderating a panel discussion among former chairpersons of the agency’s Oncologic Drugs Advisory Committee. A portion of the two-hour discussion focused on the FDA’s actions to withdraw accelerated approval of Avastin’s metastatic breast cancer claim -- and the lasting impact of that regulatory action on the accelerated approval pathway.
Pazdur: “If you take a look at the resources that went into that public hearing for Avastin, it would be impossible for the FDA to do that on a repeated basis,” he said. “I would just guesstimate that millions of dollars in resources, FTEs etc., lawyers, trying to do that hearing in a coherent fashion were spent, and probably even a greater amount by the company.”
Attention Policy Makers: Regulatory creativity, and innovation costs money.
Pazdur: “I want to put forth a general principle here. If … the agency is using accelerated approval appropriately, there will be drugs that will have to come off the market,” he said. Accelerated approval may be granted based on a surrogate endpoint that is reasonably likely to predict clinical benefit, he noted. “That doesn’t mean that it’s a definitive demonstration.”
“You have to have a balance of drugs that make it and drugs that don’t if you are really going to be demonstrating the correct degree of regulatory flexibility. If all the drugs make it basically, why call it accelerated approval?
Precisely.Read More & Comment...
According to a new report from PhRMA, the biopharmaceutical industry is the U.S.’ most research-intensive industry, dedicating 20.7% of domestic sales revenues to R&D investments in 2012.
That’s a higher percentage than the tax rate paid by President Obama!
For the year, the 31 PhRMA member companies invested an aggregate $48.5 billion in research and development. That total is down slightly from $48.6 billion in 2011 and a bit further from the record total of $50.7 billion tallied in 2010.
It is important to note that large bio/pharma companies such as Roche and Allergan are outside the scope of this report since they are not part of PhRMA so the R&D numbers would have been greater than what was reported.
“We must keep the promises we’ve already made.”
-- President Obama on Medicare
Like 12 years of data exclusivity for biologics?
The President’s budget has trotted out a deeply misguided healthcare idea. The President has his allies want to loosen "intellectual property" protection for an advanced class of pharmaceuticals called "biologics."
This is a mistake. Including this plan in any federal budget deal would inevitably undermine drug innovation, compromise care for millions of American patients, and -- ironically -- drive up long-term healthcare costs.
Unlike traditional chemical drugs, biologics are derived from living organisms. This makes them incredibly complex -- and uniquely effective. Biologics are one of the most promising modern healthcare technologies. Drug firms have already created breakthrough biologic treatments for some of the country's most prominent diseases, including HIV/AIDS, Alzheimer's and various forms of cancer.
A report from the research firm Credit Agricole predicts that six of the top twenty best-selling drugs next year will be biologics. Within five years, it's estimated biologics will comprise roughly half of the top 100 bestselling drugs in the country.
There are knock-off equivalents to biologics. They're called "biosimilars" or "follow-on biologics." However, unlike, say, that aspirin in your bathroom cabinet, a biologic can't be perfectly replicated. It's just too complex. A "follow-on" biologic will have some differences from the original.
It is possible to create a version of an innovator biologic that's close enough to the original to have basically the same therapeutic effects. Given this fact, traditional patent protections aren't sufficient to foster innovation.
This is why biologics need an additional layer of intellectual property protection. And that's where data exclusivity comes in. This statute prevents outside firms from accessing the research data behind a new biologic for a preset period of time. This way, the original inventor has a limited market monopoly, during which they can try to recoup their development costs in sales. The 12 years of exclusivity granted under the Affordable Care Act, while still less than the 14 allowed in Europe, is a good compromise.
Mounds of research shows that data exclusivity should be set at around 12 years to give the average biologic a chance to at least break even. The White House wants to scale back that period.
A recent deficit deal crafted by the administration included a provision that would scale back the period of data exclusivity granted to biologics from 12 to 7 years. The idea is that allowing lower priced biosimilars to flow into the market sooner will drive down costs for public insurance programs and generate major savings for the federal treasury.
While shortening biologic data exclusivity could generate some short-term financial gains, it will ultimately reduce the rate of medical innovation and deprive American patients of life-saving new treatments.
The brute reality is that if data exclusivity drops to seven years, many biologic innovators won't have enough time to make back their original investment before biosimilars flood the market and siphon away their profits.
After all, creating a biologic is an incredibly expensive, time-consuming, and risky endeavor. The average biologic costs well over a billion dollars to develop. For every 10,000 compounds tested in the lab, only one will wind up getting federal approval and making it to market. And simply making it to market is no guarantee of profit. Only about three out of every ten new pharmaceutical medicines will ever recoup back its development costs in sales.
If the government reduces the exclusivity window for biologics, many drug firms will actually end up losing money on that massive investment. That leaves less capital to pour into new drug research operations. And outside investors will be less willing to underwrite new research initiatives given that their chance of even breaking even on a new treatment has dropped significantly.
Ultimately, that means fewer new drugs for American patients.
The Obama administration and its allies need to drop this push to scale back data exclusivity protections for biologic drugs. These treatments have proven to be highly effective at improving patient health and saving lives. Diluting the intellectual property rights protecting biologics will slow down the rate of innovation and choke off the flow of new treatments.Read More & Comment...
"We should never be defensive; we should never temper our passion for the positive impact that we can create together for patients, for our economy and for our country. And we should take this optimistic vision of the future and our passion for innovation to policymakers in this country and around the world. "
When's the last time a drug or biotech trade group leader actually stood up for commercialization instead of apologizing for it or stated that commercialization of medical science is the source of most of the world's progress in the past half century? Hugin just didn't restate PhRMA's agenda, he made a case for pushing it without pride.
Celgene's corporate campus is bracketed with banners that proclaim: "Discovered Here. Developed Here. Commercialized Here." It sounds like Hugin is carrying that message into his tenure as PhRMA chair.
Read More & Comment...
Remember the game show Password? The program’s slogan was “It’s not what you say -- it's what you don't say.”
And so it is with the sequester at the FDA. It’s not what the agency is doing – it’s what they’re not doing.
According to an article in the April edition of Nature Biotechnology:
The budget sequester is “not the end of the world, but it’s not good for FDA,” says Peter Pitts, president of the Center for Medicine in the Public Interest in New York. For example, PDUFA dates may need recalibrating. US Department of Health and Human Services (HHS) secretary Kathleen Sebelius has warned that FDA cutbacks will heighten food safety risks from fewer inspections, but Pitts points to longer-term strategic effects arising from the sequester. “Anything having to do with policy development, such as dealing with biosimilar drugs, will grind to a halt,” he says. “The sequester will delay regulatory innovation by pushing things that are important but not life-threatening off the agenda.”
It’s the invisible hand of innovation postponed that is the most pernicious aspect of the White Oaks sequester.
The complete Nature Biotechnology article can be found here.Read More & Comment...
Here's the Federal Register notice announcing the 12 disease areas that have been selected by FDA for the PDUFA V patient-focused drug development meetings in FY2013-2015.
SUMMARY: The Food and Drug Administration (FDA) is announcing the selection of disease areas to be addressed during the first 3 years of Patient-Focused Drug Development. This 5-year initiative is being conducted to fulfill FDA’s performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). It provides a more systematic approach for the Agency to obtain patients’ input on specific disease areas, including their perspectives on their condition, its impact on daily life, and available therapies. FDA selected these disease areas based on a set of selection criteria, the perspectives of the reviewing divisions at FDA, and the public input received on a preliminary set of disease areas published in the Federal Register on September 24, 2012.
FDA has selected the following diseases to be addressed in FY 2013–2015:
* Alpha-1 antitrypsin deficiency;
* breast cancer;
* chronic Chagas disease;
* female sexual dysfunction;
* hemophilia A, hemophilia B, von Willebrand disease, and other heritable bleeding disorders;
* idiopathic pulmonary fibrosis;
* irritable bowel syndrome, gastroparesis, and gastroesophageal reflux disease with persistent regurgitation symptoms on protonpump inhibitors;
* lung cancer;
* myalgic encephalomyelitis/chronic fatigue syndrome;
* neurological manifestations of inborn errors of metabolism;
* Parkinson’s disease and Huntington’s disease;
* pulmonary arterial hypertension;
* sickle cell disease