Latest Drugwonks' Blog
At the recent BIO confab in Philly I was honored to moderate the panel on “Public Sector Biotech Initiatives in Middle East and North Africa.” I was joined with public officials and regional experts (Marwan Abdulaziz Janahi, Executive Director of Dubai Biotechnology and Research Park, DuBiotech, Samir Khalil, Executive Director of Middle East & Africa, PhRMA, Tarek Salman, Assistant Minister of Health and Population for Pharmaceutical Affairs in Egypt, David Torstensson, Senior Consultant, Pugatch Consilium, and Jeffrey Kemprecos, Executive Director, Emerging Markets Public Policy, Merck).
A key take-away was that one of the key drivers of biotech investment in the region (and, indeed, any region) is sound regulatory policy. This was most directly addressed by Vice Minister Salman who discussed how the Egyptian regulatory authority had upgraded both its processes and procedures to reward innovation with a review pathway that is more predictable and timely.
As the panel’s moderator, I had the opportunity to present opening remarks. Here’s what I had to say:
When it comes to biotech incentives in the MENA region, there are many languages, priorities, pressures, and impediments (social, political, cultural) to consider.
In April 2015 I spent three fascinating days in Sharm El Sheikh, Egypt at the Second Arab Conference on Food & Drugs.
Delegates from the Levant to Morocco had a lot to say and share. The fundamental take-away was that the Arab world is serious about coordinating their efforts in healthcare in general and in regulatory affairs specifically. “Convergence” and “harmonization” were the two key words of the event.
(The Middle East/North Africa Region – MENA – consists of 22 nations – but just 2% of global pharmaceutical sales.)
Biotech initiatives are a global opportunity, but they take many local forms --because public health is a global fraternity with national priority, local impact and global implications.
Biotech Initiatives take many forms:
- Investment programs
- Clinical trial incentives
- Reinvention of medicine and device regulation
- A high regard for Intellectual Property Rights
- An embrace of the concept of both price and value
- Transparency of laws and regulations
- And the rule of law
Most importantly, national biotech initiatives rest on the foundation of the importance and urgency of healthcare innovation.
But Biotech Initiatives mustn’t falter under the false banner of Biotech Imperialism. Initiatives must benefit all parties, transnational, national – and local.
That means “doing the right thing.” It’s about “Nazaha” – Integrity.
This happens everytime a bunch of new medicines hit the market. But how about putting the amount into context or discussing value. As any baseball fan (or FBI agent investigating the St. Louis Cardinals hack of the Houston Astros scouting database) knows context is everything.
So for instance, the Pharmalot blog posted: How Much?! Global Prescription Drug Sales Forecast to Reach $987B by 2020
But the headline obscures and deflects attention from the fact that between 2015-2020 Rx spending will actually decline as a total share of global health spending.
The same designed neglect applies to the breathless discussion of "skyrocketing drug prices or drug costs".
You wouldn't know that drug spending as a percent of total health spending in the US will remain FLAT between now and 2025 even as specialty drug spending becomes half of total Rx expenditures.
Is it too much to ask for some context. It took me, a C minus math student, five minutes to figure out percentages. Why can't journalists and policy types who are a lot better at this stuff than I am run the same numbers?
Per a report in BioCentury, PatientsLikeMe Inc. has granted FDA access to its patient-reported data, which the agency said it will use to identify risks and benefits of drugs. The agency said PatientsLikeMe's adverse event data have the potential to supplement existing sources, including data that sponsors are obligated to report and data from FDA's Adverse Event Reporting System (FAERS), to address safety issues that arise postmarket. PatientsLikeMe said FDA will have access to more than 110,000 adverse event reports on 1,000 different drugs at no cost. The data include information on drug tolerance, adherence and quality of life. PatientsLikeMe President Ben Heywood told BioCentury the collaboration "may lead to FDA-sponsored research projects designed to understand how patient-reported data might be used to enhance post-market surveillance, support regulatory decision making and inform regulatory science." FDA also operates the Sentinel system, with which it can query electronic health records to identify and monitor postmarket safety concerns.
From the pages of the Houston Chronicle:
Pitts: Obama's drug crusade comes at high price
Medicare Part D program, which provides affordable drug insurance, needs to be emulated, not reformed
A new federal report misleadingly estimates the cost of the Medicare Part D program at $103 billion. That figure is bunk. Nonetheless, it will give President Barack Obama more ammunition for his assault on Part D - a program that provides affordable prescription drug insurance to more than 2 million Texas seniors.
Already, the president has pushed for government controls on drug prices in Part D - a "reform" he endorsed in his 2016 budget.
But Part D doesn't need to be reformed - it needs to be emulated. The program is a historic success. Federal interference in Part D drug pricing would destroy that success and drive up the cost of medications, reduce enrollee choice, and harm patients.
Part D drug coverage is affordable for seniors and taxpayers alike. The average monthly premium for a Part D plan is around $32 - and hasn't changed much over the last five years.
Nearly a decade after Part D was created, the program's overall costs are almost $350 billion below initial estimates, according to the Congressional Budget Office.
Unsurprisingly, the program is enormously popular. Among beneficiaries, Part D's satisfaction rate is roughly 90 percent.
Yet the Obama administration wants to tamper with the program by bargaining directly with drug manufacturers for rebates on Medicare prescriptions.
Currently, the law that established Medicare Part D prohibits federal officials from interfering "with the negotiations between drug manufacturers and pharmacies and [prescription drug plan] sponsors."
The Obama administration views this lack of government negotiation as a shortcoming that boosts Part D's cost. But non-interference is actually essential to the program's success.
Indeed, the reason the program is able to deliver satisfactory coverage at such a reasonable cost is its competitive structure. Under Part D, Texas beneficiaries are free to choose from 32 different private coverage plans.
In order to win customers, plan providers compete with each other to offer the best policies at the lowest cost, driving down prices in the process.
This arrangement works because private insurers are able to secure their own drug rebates through private negotiations with pharmaceutical firms. These rebates frequently amount to a 20 or 30 percent discount. And those savings are passed on to beneficiaries.
If the federal government intrudes on private Part D negotiations, the competition driving the program's success will collapse. Drug prices will go up. Quality of plans will go down.
Worse, federal interference in the negotiations wouldn't result in lower drug prices, as the Obama administration claims. Researchers from the Congressional Budget Office have concluded that government officials "would be unable to negotiate prices across the broad range of covered Part D drugs that are more favorable" than the prices achieved by private insurers.
Unfortunately, the administration's rhetoric against Part D ignores these existing discounts. The $103 billion figure, which comes from a Center for Medicare and Medicaid Services report, doesn't account for the discounts either. CMS simply tallied up the market price of all drugs dispensed through Part D.
Factoring in those privately negotiated rebates paints a more accurate picture of Part D annual costs, which are closer to $62 billion.
Federal intervention won't lower Part D's total cost, but it will make it harder for seniors to get the medicines they need. According to Douglas Elmendorf, the former head of the Congressional Budget Office, negotiating for a lower drug price on a given drug carries "the threat of not allowing that drug to be prescribed." Beneficiaries could loss access to treatments they now depend on to stay healthy.
Sadly, none of these facts have stopped the Obama administration from trying to interfere in Part D price negotiations. But it's important to ask: What does the president hope to accomplish with his proposal?
If the president's aim is to expand access to affordable prescription drugs, he should be celebrating Part D - not trying to destroy it.
Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.
To that point, a new op-ed from today's edition of the Wall Street Journal.
The Patent Trial and Appeal Board was supposed to make the system better. It hasn’t.
BY: Peter J. Pitts
When Ultratec, a manufacturer of closed-captioned phones for the deaf, realized that a rival had created a knockoff using its patented technology, the company filed a patent-infringement lawsuit. A Wisconsin federal jury ruled for Ultratec in October, ordering rival Sorenson Communications to pay $44 million in damages.
But Ultratec may never receive a cent. In March a little-known but hugely powerful federal body called the Patent Trial and Appeal Board (PTAB) invalidated Ultratec’s patents, on grounds that the designs were too obvious to be patentable.
The PTAB, created by the 2011 America Invents Act, was intended to strengthen the patent system. Lawmakers hoped to avoid the need for patent lawsuits by giving patent holders and challengers a quick and inexpensive way to resolve disputes as an alternative to the courts.
But the board uses looser standards than a federal court to evaluate a patent’s legitimacy. Courts assume that a patent is valid until a challenger provides “clear and convincing” evidence to the contrary. The PTAB requires only that challengers show that it’s more likely than not (i.e., a “preponderance of the evidence”) that a patent is too broad.
In recent months the board has overturned patents on a computer memory technology, a popular videogame, and a system for monitoring car tires. The PTAB has invalidated at least one “claim”—or part—in almost 80% of the patents it has ruled on, according to a study in the University of Chicago Law Review. Some patent experts such as Randall Rader, former chief judge at the U.S. Court of Appeals for the Federal Circuit, have referred to the 300-odd administrative judges, attorneys and legal aids on the board as “patent death squads.”
Patent challengers have jumped at the chance to exploit the board’s lax standards. Since it began to operate in September 2012, the PTAB has received more than 2,600 patent challenge requests—three times more than it expected.
Many of these challenges—such as one against Combigan, an eye-drop medicine that prevents blindness in patients with glaucoma—seek to overturn patents that district courts have already upheld. In many other cases, the patents have also been challenged in federal courts—but courts have stayed the litigation until the PTAB has ruled. The patent may be invalidated without facing a court’s stricter standard.
The PTAB could devastate innovation-intensive industries. Consider pharmaceutical developers, which spend about $51 billion a year researching new treatments. But less than 12% of drugs that reach clinical trials ever make it to market.
Patents give firms the financial incentive to fund challenging research and development projects. In the event that a huge upfront investment results in a popular new product, the developer can recoup its costs in sales.
The PTAB jeopardizes this process. Since an overturned patent means that rival companies could create knockoff products, firms will lose the confidence that they’ll reap the rewards of innovation.
Some financiers have started using the PTAB to make a quick buck. Kyle Bass is a hedge-fund manager, not a pharmaceutical developer, but he recently challenged six drug patents. His strategy, which has been widely reported, is to bet that the challenges would drive down the patent owners’ stock prices.
The strategy is working. Early this year Mr. Bass challenged Acorda Therapeutics ’ patent on Ampyra, a medicine that uses a re-engineered bird poison to help multiple sclerosis patients walk. The claim: Medical experts would have been able to deduce the effectiveness and proper dosing of the re-engineered molecule. The challenge caused the company’s stock price to drop almost 10%.
If hedge funds and copycats continue to take advantage of the PTAB’s bias against patent holders, it will choke off funding for lifesaving medicines.
The Patent Trial and Appeal Board will make it harder to create the products that improve lives and fuel the economy. To avoid this dangerous outcome, Congress has to reform the PTAB so that it operates under the same standards as a regular court.
Mr. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.
(Some animals are more equal than others.)
It's an important, timely, fun -- and a must read pre BIO and DIA.
Enjoy.
What does the FDA think of Amarin's plan for off-label communication?
Here's the letter the agency sent them. And, from the pages of the Wall Street Journal,the latest on Amarin's lawsuit and the FDA's counter-strategy.
FDA Tries to Blunt Amarin’s Free-Speech Lawsuit Over Off-Label Info
By Ed Silverman
Last month, a small drug maker called Amarin AMRN -4.82% caused a stir by filing a lawsuit against the FDA to argue that its right to distribute information about unapproved uses of a medicine is protected by the First Amendment.
Now, in an unusual move that appears designed to blunt the impact of the lawsuit, the FDA has written a letter to Amarin saying the types of materials the drug maker would like to distribute to doctors actually would not be a problem. And the FDA suggests that Amarin might have known this if the drug maker had discussed the issue before filing its lawsuit.
The lawsuit is being closely watched for its potential to determine whether the FDA can prohibit drug makers from distributing off-label information. The issue has been widely debated after a federal appeals court in 2012 overturned a criminal conviction of a sales rep for promoting off-label uses. The court ruled his speech was protected, since the information was truthful and not misleading.
As we reported previously, Amarin wants to be able to provide doctors with information that does not directly pertain to the approved uses of its Vascepa prescription fish-oil pill. The FDA endorsed the drug to treat people with very high levels of triglycerides, a type of fat in the blood that can lead to heart disease.
But two months ago, the FDA rejected an Amarin bid to market its pill to patients with slightly lower triglyceride levels and denied its plan to add effectiveness data to the Vascepa product labeling. Amarin then filed its lawsuit, arguing it has a constitutional right to distribute the information, even though such a move would be considered by the FDA to be off-label promotion.
In its lawsuit, Amarin included a list of medical journal articles it would like to distribute to physicians. However, the FDA writes that none of these are problematic. The agency “does not have concerns with much of the information you proposed to communicate” and the FDA “would not consider the dissemination of most of that information to be false or misleading,” the FDA letter to Amarin states.
As it turns out, the FDA says that Amarin never approached the agency about the issue. In her letter, FDA official Janet Woodcock makes a point of writing that Amarin “did not ask for our views before filing” its lawsuit “as other pharmaceutical companies sometimes do.” A spokesman for Amarin says the drug maker would not comment.
Moreover, Woodcock also reiterated FDA plans to release a so-called industry guidance for governing the dissemination of off-label information. In effect, the letter amounted to a pre-emptive move that might slow the progress of the lawsuit, according to regulatory experts.
“I think Amarin is frustrated by the results of its dealings with FDA and has resorted to the courts instead of trying to maintain a constructive dialog with FDA,” says Ira Loss, senior health care analyst at Washington Analysis, a consulting firm. “Woodcock’s letter undercuts their case. Not talking to FDA before filing the suit will likely result in a summary judgment for the agency.”
Adds Peter Pitts, a former FDA associate commissioner for external affairs, who now does policy consulting for the pharmaceutical industry: “Amarin got some bad regulatory advice. The FDA has loudly signaled that it is going to act with increased regulatory discretion on off-label communications. This was either missed or ignored by Amarin.
“… A meeting with the agency would have addressed their concerns. [As for the FDA], “exercising regulatory discretion is a smart move as it takes the matter out of the hands of a judge. A free speech ruling would make things much more difficult for the agency. The FDA opted for strategic retreat rather than face a potential sledgehammer legal decision.”
Now, innovation is NOT invention. Here's Sir Harold Evans, another very smart person on this issue: innovation is bringing an invention to use (i.e. commercialising it)...a scientist will have understanding, an inventor will have a solution but an innovator will have a universal solution.
An invention without innovation is a past-time. Essentially, many inventors are hobbyists, since an MIT study has shown that fewer than 10% of patents granted have had any commercial application.
Evans says that few scientists are able to turn ideas into a commercial impact.
Which leads me to the NIH' foolish foray into drug development.
Innovation is about commercialization. Commercialization especially today requires something that is in large supply in the private sector and short supply at the NIH:
Experience in commercialization, which includes constantly learning from failure in the development of a product that one hope's will have mass appeal and consumption.
Further, as a Fast Company article notes: ln a world of rapid disruption, having a core competency—that is, an intrinsic set of skills required to thrive in certain markets—is an outmoded principle of business. Just as Google needed Android to attack mobile and Apple needed Siri to pursue search, thriving businesses need to constantly evolve, either through partnerships, new talent, acquisitions—or all three. Nike, No. 1 on Fast Company's 2013 list of Most Innovative Companies, proves this idea more than most. Last year, it launched FuelBand, a high-end electronic wristband that tracks your energy output and signaled Nike's growing strength in the digital realm. "Think about it: Nike is now included in conversations around technology—it's shifted into an adjacent industry, breaking out of apparel and into tech, data, and services," says Forrester Research analyst Sarah Rotman Epps. "That strategic shift is incredibly important to Nike's future."
NIH has been throwing little bits of money to keep up with the furious pace of evolution and the rapid shift of life science firms into related industries. It looks a little desperate but there's no choice because most of what NIH does and spends money on are discoveries and technologies developed outside it's walls.
Thus, while it was great to see that the NIH and FDA is looking for an entrepreneur in residence (for database analysis), I had to laugh since the idea of an entreprenuer locked inside government regulations and surrounded by people who's job longevity depends on avoidng risk and stifling others has the makings of a great comedy sketch.
Add to that the fact that entrepreneurs commercialize.. How can you do that when you have little experience scaling up clincal trials with safe and consistent and ample supplies of the materials you need to make something.
Ask people at the FDA what they think about the ability of NIH bureaucrats and researchers to engage in drug development. It's a good way to get them to laugh for a change.
I won't go into the demise of government run vaccine development facilties. I will mention that even before NIH contaminates samples that it is not very good at deciding what to develop or not.
Further, the NIH is horrible at clinical trial recruitment and management. Just ask cancer patients who on average wait 800 days for NIH sponsored trials to get up and running. Here's what Vince DiVita, the former head of the NCI said in 2008. Sadly, it is still relevant today.
"The requisite talent to know the right way to design and modify an ongoing study does not reside on remote review committees at the NCI or the FDA, yet those are the places where the delays are greatest. Too many cooks are spoiling the broth."
As John LaMattina points out When NIH was asking for funding for the National Center For Advancing Translational Science (NCATS) Dr. Roy Vagelos, the legendary former Merck CEO and now Chairman of the Board of Regeneron Pharmaceuticals. Testifying before the subcommittee as an adviser to the American Society for Biochemistry and Molecular Biology, he made the following point:
“Does anyone in the audience believe that there is something that NCATS is going to do that the industry thinks is critical and that they are not doing? That is incredible to think that. If you believe that you believe in fairies.”
In fact, what NIH has done has pull funding from the Molecular Libraries Program which supported has made a contribution to the development of drug discovery tools. These tools have, in the hands of Hugh Rosen, who runs a lab at Scripps, revolutionized drug discovery. Rosen's work only led to the development of biotech startup Receptos which has several drugs under development and as well as the development of a drug to control the cytokine storms that cause sudden death in people with the flu. So what did NIH do? It not only rejected future grant requests from MLP participants it pulled the money that would have supported improvements and next generation tools and it put it into the NCATS, the government's drug company. That's not what entrepreneurs do unless they want to waste money. As one advisor to the Molecular Library Program noted the kind of spinoff for which Receptos is the poster child is “something that has come from this and is probably going to disappear.”
Think of NIH as a $30 billion business that has strayed from it's core competency: funding outside the box research and ideas and supporting small groups of researchers who contribute to and interact with anyone that seems to be solving key research questions and wants to turn them into products. The way back is to democratize and de-routinize grant giving and break up the cartel of research centers that rely upon NIH money for overhead. Craig Venter's suggestion should be taken seriously:
"The academics might not like it, but peer review is like the prisoners running the prison. They're not going to vote for change. Universities like this system because it helps support the universities. We have to change it so that 25%, 30%, 40% of the money is set aside for true risk research with independent parties to do that. That's going to disrupt a lot of things. I argue that the American public should be outraged that there's not 10 times to 100 times more breakthroughs in medicine every year over what we're getting, particularly for the money that's being spent."
Congress is likely to increase NIH funding. Unfortunately, the influx of cash will go to waste without the kind of mission change Venter has suggested.
From the pages of the Orange County Register
The FDA has patients playing a dangerous name game
What's in a name? In medicine, it could be the difference between life and death.
A new class of drugs is coming onto the U.S. market. Unfortunately, Congress is standing by as the Food and Drug Administration prepares to allow marketers to sell these imitations under the same name as the original drug.
The only problem is that the drugs aren't the same. The differences between the drugs, although subtle, can have serious consequences for patients' health. Lawmakers should instruct regulators to acknowledge these differences by establishing a naming system that distinguishes between the knock-offs and the originals.
The new drugs are "biosimilars." They're inexact copies of biologics – a type of complex drugs derived from living cells. Because living cell strains can't be replicated exactly, the biosimilar drug grown from these cells is also impossible to copy exactly. They're similar, but not identical – and that's the problem.
Biosimilars produced by different manufacturers have similar properties but are not identical to the original or each other.
The medical field rightly values precision, and the ability to trace side effects back to a specific drug is a crucial patient right. To protect that right, Congress should instruct the FDA to develop a clear-cut naming system that calls different medications by different names.
A study conducted in Ireland revealed important distinctions between biosimilars and the biologics on which they were based. The study found variations when Inflectra, a biosimilar that treats rheumatoid arthritis and Crohn's disease, was tested against the biologic it tried to copy. While only 5 percent of patients who received the biologic required hospital readmission, 80 percent of the Inflectra group did.
In addition, just 8 percent of the biologic patients needed multiple bumps in steroid dosage for effective treatment, but 50 percent of Inflectra patients required them. The authors of the study concluded that biosimilars might be less effective than the original biologics.
The FDA itself noted that it's first-ever commercially approved biosimilar, Zarxio, has a lower protein content than filgrastim – the original biologic. The agency dismissed the difference as a manufacturing flaw. But because biosimilars don't undergo extensive clinical trials, drug defects or harmful side effects will be detected only after they enter the market. When side effects do occur, calling different drugs by the same name would subject patients to an impossible guessing game. Did Patient A take the original filgrastim or biosimilar Zarxio?
Fortunately, the FDA's naming system is trying to address this problem. The FDA is calling Zarxio "filgrastim-sndz."
That suffix, representing the drug's manufacturer name "Sandoz," is better than no distinction, but it's still problematic. That's because a suffix shouldn't be tied to the manufacturer's name.
If Sandoz changes its name, or merges with another drug company that makes its own knockoff version of filgrastim, the four letter suffix would lose all meaning. "Sndz" is not a clear-cut differentiator that would follow a drug from patient to patient, year to year. A constant alpha-numeric suffix like "aaa123" would be considerably more effective.
The FDA must recognize that Zarxio and filgrastim are different products and have different side effects. Common sense dictates they should have different names.
Congress and the FDA need to recognize this and implement a distinct naming system before patients get hurt. Zarxio and filgrastim are almost copies of each other. But giving them the same name is akin to almost healing a patient or finding almost the right diagnosis. It's just not good enough.
Peter J. Pitts, a former FDA Associate Commissioner, is president of the Center for Medicine in the Public Interest.
From FDA Law Blog:
Return of the Scarlet Letter? AbbVie Petitions FDA to Require Biosimilar Labeling to Include Disclaimers and a Description of Data Differences
By Kurt R. Karst –
It was just a few weeks ago that we noted in a post concerning FDA’s recently finalized guidance document on “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product” that the Agency removed from the 2012 draft version of the document any requirement that the labeling of a biosimilar biological product licensed under PHS Act § 351(k) indicate that it is biosimilar to a reference product, and also to call out whether or not it is interchangeable with a reference product. As we commented then, “[w]hile such designations may not have made a biosimilar feel like Hester Prynne, it does seem that mandating such terms be present may have led to some shunning in the marketplace that is today’s town green.”
It seems that AbbVie Inc. (“AbbVie”) – which, interestingly, starts with the letter “A” – took note of the Scarlet Letter change as well. In a June 2, 2015 Citizen Petition (Docket No. FDA-2015-P-2000) that popped up on regulations.gov earlier this afternoon (June 3rd), the company requests FDA to require the approved labeling for biological products licensed under PHS Act § 351(k) to contain (if applicable) certain statements and descriptions that would differentiate biosimilars from their reference product counterparts. Specifically, AbbVie wants biosimilar labeling to include:
A clear statement that the product is a biosimilar, that the biosimilar is licensed for fewer than all the reference product’s conditions of use (if applicable), and that the biosimilar’s licensed conditions of use were based on extrapolation (if applicable);
A clear statement that FDA has not determined that the biosimilar product is interchangeable with the reference product (if applicable); and
A concise description of the pertinent data developed to support licensure of the biosimilar, along with information adequate to enable prescribers to distinguish data derived from studies of the biosimilar from data derived from studies of the reference product.
Biosimilars, which came about with the March 23, 2010 enactment of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), “are not generic drugs and should not be labeled like generic drugs,” says AbbVie in its petition. Including in biosimilar labeling the items above “is necessary to enable rational and informed prescribing decisions regarding these complex products, to avoid potentially unsafe substitution of biosimilars and reference products, and to combat widespread misconceptions among prescribers about biosimilars and their relationship to reference products,” writes the company. Furthermore, without such differentiating statements and description, “biosimilar labeling will not reflect the unique licensure provisions established by the BPCIA and will be materially misleading in violation of the FDCA and FDA regulations.” And, in what might be a signal of future litigation, AbbVie alleges that FDA’s “about-face” reversing, without explanation, what the Agency proposed in the 2012 draft guidance is a violation of the Administrative Procedure Act (“APA”). (Though, keep in mind that the last time Abbvie – then Abbott Laboratories – petitioned FDA on the BPCIA back in 2012 – concerning Reference Product Exclusivity – we though a lawsuit might be looming – see our previous post here. That didn’t happen – at least it hasn’t yet.)
Pointing to FDA’s March 6, 2015 approval of BLA 103353 for Sandoz Inc.’s (“Sandoz’s”) ZARXIO (filgrastim-sndz), a biosimilar version of Amgen Inc.’s NEUPOGEN (filgrastim), AbbVie says that FDA long ago made the decision to apply the “same labeling” requirement under FDCA § 505(j) (applicable to ANDAs) for small-molecule generic drugs to biosimilars licensed under PHS Act § 351(k):
Publicly available materials from FDA’s review of Zarxio confirm that FDA followed a “same labeling” approach. According to the action package for Zarxio, in November 2013, Sandoz proposed and FDA agreed that the biosimilar and reference product labeling “should be essentially the same.” In February 2015, FDA provided the labeling for Neupogen to Sandoz for use “as a template” in developing the labeling for Zarxio, and instructed Sandoz to track any changes made to the Neupogen labeling and provide annotations to explain and justify any such changes. That is essentially what FDA regulations require of applicants seeking to market generic drugs under section 505(j). Indeed, in the media briefing announcing the approval of Zarxio, the Director of the Office of New Drugs in the Center for Drug Evaluation and Research (CDER) acknowledged that the “approach” taken with respect to the labeling for Zarxio was “not that different from the approach . . . taken in the past . . . for generic applications.” Consistent with that approach, the approved labeling for Zarxio is nearly identical to that of Neupogen . . . .
According to AbbVie, however, applying the FDC Act’s ANDA “same labeling” approach to to biosimilars is legally unsound. AbbVie then ticks off the reasons why such an approach doesn’t comport with the law.
“First, a ‘same labeling’ approach is flatly inconsistent with the BPCIA, which—unlike the [ANDA] provisions in section 505(j)—includes no ‘same labeling’ requirement and recognizes that biosimilars are different from their reference products. . . .” (Emphasis in original). Here, AbbVie compares and contrasts the BPCIA and the FDC Act, noting, among other things, that the BPCIA specifically amended the FDC Act (at FDC Act § 505B, concerning required pediatric studies) to provide that a non-interchangeable biosimilar biological product “shall be considered to have a new active ingredient” (at least for purposes of FDC Act § 505B).
“Second, a ‘same labeling’ approach to biosimilars would result in labeling that omits material information necessary for safe and informed prescribing, and would exacerbate, rather than dispel, misconceptions among prescribers regarding biosimilars.” Here, AbbVie argues that applying a “same labeling” approach to biosimilars violates the FDC Act’s misbranding and misleading labeling provisions at FDC Act §§ 502(a) and 201(m), respectively.
Third, AbbVie argues that “FDA has not provided the reasoned explanation required by the APA for its decision to abandon the approach taken in the Draft Scientific Guidance, which stated that the labeling of a biosimilar product should disclose that the product is a biosimilar, the scope of its approval, and whether it has been found to be interchangeable, on the ground that this information is ‘necessary’ for informed prescribing.” Going through the record of FDA meetings and comments leading up to and on the draft guidance, AbbVie asserts that “FDA’s decision to reverse course and adopt a same labeling approach for biosimilars is arbitrary and capricious.”
AbbVie’s petition includes a certification under FDC Act § 505(q), which was made applicable to petitions affecting pending Section 351(k) biosimilar applications under the 2012 FDA Safety and Innovation Act. This is, by our count, the second citizen petition involving the BPCIA containing such a certification. FDA denied the first 505(q) biosimilar petition earlier this year (see our previous posts here and here). If FDA tags AbbVie’s petition as a 505(q) petition – which seems probably given the likley pending status of Section 351(k) applications at FDA that could be affected by the petition – then we can expect some sort of response within 150 day
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.
