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Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: Waxman

Trends Update — Biosimilars: The State of Play of U.S. Follow-on Biologics Legislation

With the Senate Finance Committee voting this week in favour of its health reform bill, the legislative process will now move on to an attempt to reconcile the House bill and the two Senate bills in conference.

What does this mean for a biosimilars pathway?  Will there be one?  What will the exclusivity period be?  The Senate Finance bill is silent on the topic, and the two other bills both include a biosimilars pathway with a 12-year exclusivity period.

Twelve years makes the Biotechnology Industry Association (BIO) and the National Venture Capital Association pretty happy, but the Obama administration and  the FTC argue in favo(u)r of a much shorter period.

Today, a new opinion piece in the New England Journal of Medicine generated a lot of buzz, mostly because it argues for a 5-year exclusivity period (but also because it was an odd roll-out for NEJM’s new conflicts disclosure policy).

When the In Vivo Blog polled the question earlier this year, the majority vote was for 10-12 years; but me and some peeps on twitter (hi @InVivoBlogChris and Maureen @FierceBiotech) and in real life (anonymous) thought at the time the number would land under 10 years.  I’m sticking to that bet.

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Trends Update — Biosimilars: Obama Administration Supports 7-Year Exclusivity Period

The Obama administration offered up a 7-year data exclusivity period for biologics, calling it a “generous compromise” in a letter to Rep. Waxman from Nancy-Ann DeParle, director of the Office of Health Reform, and Peter Orszag, director of the Office of Management and Budget, picked up by Bloomberg this week.

I’ve had my money on an 8-10 year period for a while now as the compromise between the competing Waxman and Eshoo-Barton bills … The InVivo Blog has a funny take on how a 10-year period might be injected into the dialogue.

BIO points to a post by Prof. Holman criticising Waxman’s 5-year period (now clearly an outlier) and also the patent challenge/enforcement provisions of Waxman’s bill.

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FTC Weighs In: Favors Compromise on Biosimilars Exclusivity, Disfavors Pay-For-Delay

The FTC released a report today that explores the economics of biosimilars’ market entry and competition.  It predicts that biosimilars will be priced only 10 to 30% under their corresponding pioneer biologics; and that pioneer biologics will retain 70-90% of their market share subsequent to biosimilar market entry. 

Based on these predictions, the FTC concludes that the proposed 12-14 year exclusivity period (here’s looking at you, Eshoo-Barton) is “too long.”  I’m sticking with my guess that we see a compromise from Waxman on the exclusivity period, landing around 8-10 years.

The report also reiterates the FTC’s opposition to pay-for-delay deals and corresponding support for H.R. 1706.

P.S. The InVivo blog says there’s convergence on “biosimilars” over  “generic biologics” and “follow-on biologics” as the nomenclature of choice (presumably “subsequent-entry biologics” loses too), so I’m running with it.

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Hearings on the Medical Device Safety Act of 2009

Reps. Waxman and Pallone introduced legislation in March, with a parallel effort by Sens. Kennedy and Leahy, to moot the Supreme Court’s decision in Reigel v. Medtronic and reinstate (har) state tort liability for PMA-approved medical devices.

This week, they held a hearing on the bill – H.R. 1346, the Medical Device Safety Act of 2009. 

The witnesses were (click for their statements):

There is also video of the hearings available.

Opening Statements:

Panel Testimony:

Panel Questions:

More to come when I get a chance to dig in…

Trends in 2009: Shifting IP Constituencies as Innovator Pharma Buys Generics and Asia Turns to Innovation

Growing industrial and geopolitical realignment of economic interests has the potential to re-define intellectual property constituencies in 2009.

1.  Industrial realignment: the entry of innovator pharma companies into the generics business.

This year has already seen Merck get into follow-on biologics by buying Insimed and Pfizer build its generics business with its Aurobindo deal.  As traditional innovator pharma companies become more invested in follow-on biologics and small molecule generics, they will have a greater (self-)interest in a functioning subsequent entry pathway. 

Watch how this is playing out in the follow-on biologics arena as two competing FOB bills make their way through Congress.  Right now, the 12-year exclusivity period in the Eshoo-Barton FOB bill and the 5-year exclusivity period in Waxman’s FOB bill are duking it out, and we’re already seeing increased industry flexibility.  Innovator pharma has historically insisted on a 14-year exclusivity period to accompany follow-on biologics legislation, but BIO has already indicated some willingness to support Eshoo-Barton, as has PhRMA

Dani’s the expert, but my layman’s guess is that we get a FOB pathway this time around, and that the exclusivity number lands somewhere in the 8-10 year range.  This is consistent with a Teva-promoted analysis and it’s easy to see that it covers the arithmetic middle ground.

2.  Geopolitical realignment: increasing innovative activity in Asia, which has historically focused more on generics.

In China, a recent deal between Lotus Pharmaceuticals, Inc. (OTCBB: LTUS) and Beijing Yipuan Bio-Medical Technology Co., Ltd. (“Yipuan”) to acquire the drug Yipubishan points to China’s interest in promoting innovation.  Yipubishan, which is used to treat the symptoms of gastric ulcers and hemorrhages of the upper digestive tract, was partly funded through the use of grants from the Innovation Fund for Small – Medium Technology Based Firms of the Ministry of Science and Technology of the PRC.  Yipubishan became the first prescription drug of its kind developed in China to be included in the National Torch Project, which recognizes and promotes commercialization of high-tech discoveries and encourages companies to use high technology.  The Torch Project is one of a series of PRC Science and Technology initiatives.

In India, Wockhardt’s pioneering efforts in biotechnology are among many signs of increasing innovative activity, and have attracted interest from Pfizer and Sanofi.  Wockhardt has set up a global-scale biopharmaceuticals manufacturing powerhouse, the Wockhardt Biotech Park, in Aurangabad, India. This state-of-the-art complex comprises six dedicated, manufacturing facilities, and is designed according to US FDA and EMEA standards. It will also house new biotechnology products that are currently in various stages of development. The complex has the capacity to cater to 10-15% of global demand for major biopharmaceuticals.

India and China are in the 3rd quintile of countries in the 2009 IPRI Report, with India ranking 46/115 and China ranking 68/115 but they are steadily increasing their innovative activity. 

Within a short span, I would expect them to rank more like Israel, which has a world-class innovative industry as well as a strong generics industry (Teva), or Taiwan, which recently announced an initiative to boost cleantech and biotech.  Both Israel and Taiwan are ranked 29/115 in the 2009 IPRI Report. 

Waxman Drives Hard Bargain on FOBs Market Exclusivity

Representatives Waxman (D-CA), Pallone (D-NJ) and Deal (R-GA) released the Promoting Innovation and Access to Life Saving Medicine Act today, a.k.a. Follow-On Biologics legislation. The legislation provides a five-year initial exclusivity for products with a unique molecular structure. The Biotechnology Industry Organization is not too happy. In the past BIO has called for a 14-year data exclusivity

Perhaps actions South of the Border will move the ball forward at Health Canada on its regulatory pathway for biosimilars? It has been almost exactly a year since Health Canada’s draft guidance on biosimilars was published. Health Canada subsequently published a summary of its Consultation on the Regulatory Framework for Subsequent Entry Biologics following a stakeholder meeting in June.

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Preemption Update: Waxman and Pallone Hit the Ground Running

When we reported on the Supreme Court’s decision in Wyeth v. Levine, we wondered what the effect would be on legislation proposed by Reps. Waxman and PalloneWe did not have to wonder long — they introduced legislation yesterday, with a parallel effort from Sens. Kennedy and Leahy, to moot the Supreme Court’s decision in Reigel v. Medtronic and reinstate (har) state tort liability for PMA-approved medical devices.

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Supreme Court Rules 6-3 Against Preemption in Wyeth v Levine

The Wyeth v. Levine opinion (pdf) was handed down this morning, holding that state tort law claims (in this case, inadequate warning) are not preempted by the FDCA.  Justice Thomas’ concurring opinion starts at page 30 of the pdf.  Alito and Scalia’s dissent starts at page 54 of the pdf.

Now we have different preemption rules for PMA-approved devices (Reigel v. Medtronic), where state tort law is preempted, than for 510(k) devices (Medtronic v. Lohr) and for drugs (Wyeth v. Levine) where state law claims are still available.

Let’s see where Waxman and Pallone head with this.

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More Waxman-Pallone Reporting on State Tort Liability, Preemption, Medical Devices and FDA Approval

The NY Times Business section (and the WSJ Health Blog) this morning picked up the story — that we noted last week – that Waxman and Pallone plan to reintroduce legislation essentially reversing the Supreme Court’s ruling in Reigel v. Medtronic.  Those stories also note a Senate version to be introduced by Sen. Kennedy and Sen. Leahy.

The basis for the Supreme Court’s decision in Reigel v. Medtronic is the interpretation of the Medical Devices Amendments of 1976, so by enacting changes that specifically disclaim preemption of state tort law, Congress could effectively moot the Supreme Court’s ruling. 

However, two state-level developments may change the debate:

  1. The Wisconsin Supreme Court’s decision this week in Blunt v. Medtronic, which was dictated by Reigel v. Medtronic, may create additional pressure in favor of federal action and maintaining state tort liability (although note that only two of seven justices signed on to the Wisconsin concurring opinion decrying the result); but on the other hand
  2. The Georgia Senate Economic Development Committee held its first hearing yesterday on legislation protecting Georgia-based businesses or companies with more than 200 employees headquartered out of state from liability for defects in any drug or medical device that has been approved by the FDA.  If this initiative is successful, and is replicated in other states, both the Supreme Court’s ruling(s) and the federal legislation would be moot, since there would be no underlying state tort liability.

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Device Liability Preemption: Blunt v. Medtronic

In a 7-0 ruling that it said was dictated by last year’s U.S. Supreme Court ruling in Reigel v. Medtronic, the Wisconsin Supreme Court dismissed a products liability claim against Medtronic relating to one of its defibrillator models. 

Two justices wrote a concurrence (agreeing with the result, but) criticizing the reliance it places on the FDA’s PMA process, citing criticism of that process from within the Agency itself:

It is not at all apparent that the FDA approval process actually guarantees a minimum level of safety for medical devices.

However, the concurring  justices are mistaken to rely on the cited concerns.  The GAO and “dissident” scientist concerns, as I understand them, were about devices approved through the 510(k) process, not the PMA process, but only PMA-approved devices are exempt from State tort liability under Reigel v. Medtronic.   Medtronic v. Lohr specifically denied preemption for 510(k)-approved devices.

That is not to say that as a matter of institutional competence, I believe the FDA is better suited than the courts to assess post-approval device safety.  I don’t think we have the data to make that assessment.  Certainly if the FDA is expected to competently act as the final arbiter of product safety, it would need more funds, and perhaps revisions to post-approval regulations.  Or maybe Waxman will succeed and legislate tort un-reform.

Read our other posts on this topic.

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Rep. Waxman, Reigel v Medtronic and Wyeth v Levine

Last Summer, the U.S. Supreme Court held in Reigel v. Medtronic that the premarket approval (PMA) process for medical devices pre-empts liability under State common law for claims challenging the safety or effectiveness of medical devices.  Wyeth v. Levine, which the U.S. Supreme Court heard last Fall, but has not decided, makes a parallel argument with respect to labelling of FDA-approved drugs. Together, these two cases could reshape liability for products under the FDA’s purview in a way that looks very much like tort reform, and therefore, have seemed ripe for a legislative response.  A story in yesterday’s Minneapolis-St.Paul Star Tribune includes a statement from Rep. Henry Waxman, D- Calif. that

Waxman and Rep. Frank Pallone Jr., D-N.J., plan to introduce legislation that would circumvent the Supreme Court ruling and “protect Americans from dangerous medical devices.”

and notes that Barack Obama was one of the cosponsors of the Senate bill introduced last year to address the issue. more analysis after the jump…

News: FDA Off-Label Guidance

The FDA released updated guidance today on the use of journal articles to promote off-label uses.  Here is a link directly to the FDA guidance.

Here is the Reuters story, which notes some Congressional (Waxman) and consumer (Public Citizen’s Health Research Group) opposition, and PhRMA support.

One concern is that a permissive approach to off-label promotion will decrease incentives to file for approval of new uses.  We’re watching  to see if Wyeth v Levine will provide some new incentives in the opposite direction.

Comments on the new guidance?  Do you think it will survive in the new administration?  Discuss…

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