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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?  [...]

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 [...]

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 [...]

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 [...]

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 [...]

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 [...]

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 Pallone.  We 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. [...]

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 [...]

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. [...]

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 [...]

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 [...]

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 [...]

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