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 Register Now for our Winter Meeting
Friday, January 21 in Washington, D.C. |
Showcasing State Drug Pricing and Rebate Strategies 9:30 am - Registration 10:00 am - Introductions & Legislative Roundatable 10:20 am - Medicaid Pharmacy Reimbursement Reform Panel: Trends and Recommendations
Speakers: Mike Winkelman, Pharmacy Consultant and Nell Geiser, Change to Win Pharmacy Initiative Coordinator. 11:20 am - Recent 340B Reform Legislation and Its Implications for States
Speaker: Bill von Oehsen, President and General Counsel of Safety Net Hospitals for Pharmaceutical Access. 1:00 pm - Opportunities for Pricing Reform through Pharmacy Benefit Manager (PBM) Regulation
Speaker: David Balto, Center for American Progress. 1:30 pm - What States Should Know about International Regulation of Pharmaceutical Pricing Legislation and the Trans Pacific Partnership (TPP)
Speaker: Sean Flynn, Associate Director, Program on Information Justice and Intellectual Property.
2:00 pm - Supreme Court Update Speaker: Meredith Jacob, Pharmacy Fellow, PIJIP. 2:30 pm - Why Should State Legislators Support S.3921 the Ethical Pathway Act of 2010?
Presenters: Michael Behan, Chief Council of Senator Sanders, and James Love, Director of Knowledge Ecology International. MORE ON THE AGENDA, REGISTRATION & LOGISTICS |
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LEGISLATORS' TOOLBOX |
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From the Director
There are a number of legal issues wending their way through the courts which impact state prescription drug policy. The Supreme Court has granted certiorari in the case IMS v. Sorrell, which is the challenge to the Vermont datamining law. NLARx has joined in an amicus brief seeking Supreme Court review in an important case involving patent law and so-called "pay to delay;" read the details below. And the Obama Administration has come down on the side of the drug companies in a case brought under the 340B provisions of the public health law, in which hospitals and other providers seek restitution for price gouging.
These issues and others of interest - how to access better rebates, PBM regulation, trade policy, federal legislation -will be discussed in detail at the NLARx Winter Meeting NEXT WEEK - Friday, January 21 in Washington, D.C. - also a great networking opportunity. See the agenda and registration information in this newsletter and on our website. There is still time to register!
As always, we bring you a roundup of recent articles of interest and the Legislators' Toolbox. We hope this information is useful! If you want up-to-the-minute news postings, be sure to sign up on our facebook page.
Sincerely, Sharon Treat  |
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NLARx Joins Cipro Lawsuit Challenging "Pay for Delay" Deals That Delay Access to Affordable Medicines
On January 7, the National Legislative Association on Prescription Drug Prices (NLARx), along with the Consumer Federation of America, Prescription Access Litigation Project, U.S. PIRG and AARP, filed amicus briefs urging the U.S. Supreme Court to put an end to reverse-payment agreements, aka "pay-for-delay," in which branded pharmaceutical companies pay generic competitors, under the guise of a settlement agreement, not to market generic versions of a brand-name drug.
The NLARx amicus brief seeks certiorari review of 2nd Circuit decisions allowing the settlements, noting the substantial competitive harm - over $3.5 billion annually according to the FTC - and the need to revive the legislative intent of the Hatch Waxman Act. Attorneys General from 32 states have also filed an amicus brief urging the U.S. Supreme Court to review the deals, which the states say thwart competition and block needed access to lower-cost medications.
The case arises from a patent infringement suit in which the pharmaceutical company Bayer accused other pharmaceutical companies of infringing on its patented antibiotic Cipro, by manufacturing a generic version of the drug. According to the amicus brief, the competitors accepted Bayer's offer of $398 million in exchange for 6 years' delay. The suit claimed that this and other "pay for delay" agreements violated antitrust laws. But the 2nd Circuit, following an earlier decision regarding the prescription drug Tamoxifen, allowed the agreements to continue, even when patents had not been infringed upon.
Cipro, the brand name for Bayer's patented form of ciprofloxacin hydrochloride, is one of the best-selling antibiotics in the United States, with domestic sales of about $1 billion per year. The drug became well-known to the general public during the Anthrax scrae in the past decade, as one of the effective antibiotics to treat Anthrax poisoning.
More on the case:
States Ask Supreme Court To Review Pay-To-Delay, Pharmalot, January 11, 2011 more |
U.S. Supreme Court Agrees to Review Decision Reversing Vermont Prescriber Record Privacy (Datamining) Case
NLARx has strongly supported state laws restricting the use of prescriber-identifiable information for marketing purposes. We have a model bill and have participated in the New Hampshire, Maine and Vermont lawsuits as a "Friend of the Court," or amicus, standing with the states in support of this important legislation. NLARx Vice-Chair for Policy, New Hampshire Representative Cindy Rosenwald, drafted and enacted the first such law in the country. Vermont and Maine followed with similar laws.
Currently, the Maine and N.H. laws have been upheld by the U.S. First Circuit Court of Appeals; the Vermont law was recently overturned by the Second Circuit Court of Appeals. We support these laws because the tracking of prescriptions for marketing purposes both interferes with the doctor-patient relationship, and leads to more spending on expensive drugs rather than the most appropriate medicines and treatment.
The U.S. Supreme Court has now granted certiorari and agreed to review the appeals court decisions on the Vermont law. This case is one of first impression and is significant not only with respect to prescription drug policy in the states, but also because it will decide emerging First Amendment and other constitutional issues.
As the LA Times recently reported, "As states try to limit the marketing of costly new drugs, the Supreme Court agreed Friday to decide whether they can bar companies from buying and selling data on the prescriptions written by doctors. The case presents the justices with a novel and potentially far-reaching question on whether non-public data can be protected by the government and shielded from release, or instead whether such data deserves to be freely bought and sold on the market."
Resources and articles:
Los Angeles Times, January 7th, 2011, David G. Savage
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