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From the Director:
Between landmark rulings by the U.S. Supreme Court concerning generics and patent law; new state laws on compounding safety, importation and other topics; and trade negotiations with both Pacific rim and EU countries that affect drug pricing, its hard to keep up with the changing landscape of prescription drug policy.
Read these articles below as well as some interesting stories in the News Feed:
Importation. In the states, importing prescription drugs is back on the agenda, after several years of lessened interest. Maine has enacted legislation; will the Governor veto, and if so will the veto stick? More
Generic drugs. State legislators have consistently opposed pay-to-delay schemes, and the Supreme Court has finally ruled that legal challenges may be successful. But while consumer may benefit by greater availability of generics, the Court seems determined to preempt state law to limit liability for safety. More
Compounded drug safety. Speaking of safety, what's the current scorecard for legislation ramping up regulation of compounded drugs? There's a mixed record with pharmacists successfully tamping down many state efforts to require more oversight. More
Drug prices & trade policy. Accepting federal dollars under the Patient Protection & Affordable Care Act, AKA Obamacare, is one way states are seeking to extend access to medicines. States also continue to struggle to provide funding for state-based programs such as drugs for the elderly. This could all be for naught in the long run, though, if the manufacturers, particularly of brand name drugs, get their way in pending trade negotiations. Is this too confusing and attenuated a threat to worry about? Think again. More
Keep up with the news! Remember, in this fast-paced world the most up-to-date news about state pharmaceutical policy is posted in our Twitter feed (@nlarx) and Facebook page. We also regularly post news stories and links to reports and testimony on our
website.
 
Best wishes,
Sharon Treat, Executive Director
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States Again Look at Importing Drugs
Maine legislators have enacted significant legislation authorizing the importation of prescription drugs from several English-speaking countries. It is unclear as of this date if Governor LePage will veto the bipartisan legislation, which was championed on behalf of both private and public employers that had operated mail-order importation programs until halted last summer by the then-Attorney General. Given the strong support from legislators on both the right and left, and the pro-local business flavor attached to this legislation, if there is a veto an override is possible. This Pharmalot post provides some context and additional information about the Maine legislation. Learn more about drug importation, including online imports, at RxRights.org. You can check on the status of any veto on the Maine Legislature's website.
Meanwhile, the pharmaceutical industry is doing its best to ramp up fear of counterfeit imported drugs through industry-funded "consumer" groups, as in this MPBN radio report. In another sneaky move out of public view, the industry is trying to prevent online importation by controlling the internet domain name ".pharmacy". |
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Pay-to-Delay will Get Day in Court While Generic Manufacturers Shielded
The Supreme Court has a mixed record when it comes to pharmaceutical policy, and this year's opinions continue the trend. On the one had, the Court has ruled in favor of consumers in FTC v. Actavis. For years, NLARx and its legislative members have been weighing in opposing pay-to-delay schemes. We have signed amicus briefs, written letters, and passed resolutions. Finally, a Supreme Court decision will allow the Federal Trade Commission to challenge these deals in court on a case-be-case basis. While we would have preferred a flat-out decision that these deals aren't legal as against the pubic interest, the decision is a step in the right direction. Consumers, state governments and other purchasers or payors are expected to save. Read more here. Meanwhile in Europe, drugmakers are fined for these anti-competitive deals.
Note that these pay-to-delay deals are only one strategy drug manufacturers use to keep brand name drugs at the top of preferred drug lists and generics out of the hands of consumers. Other strategies contributing to the high cost of medicine include "evergreening" - patent extensions for minor changes in drug formulas; read more here.
While the Supreme Court's Actavis decision may benefit consumers seeking to purchase less expensive generic drugs, apparently its "buyer beware" when it comes to safety. Of particular concern to state legislators is the Supreme Court's decision in Mutual Pharmaceutical Co. v. Bartlett that FDA approval of a generic prescription drug preempts a state-law damages claim premised on the drug's design defect. Read more in Public Citizen's Consumer Law & Policy Blog and in Forbes. |
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State Legislators Have Mixed Results Regulating Compounding Pharmacies
Although according to the National Conference of State Legislatures (NCSL) 23 bills regulating compounding pharmacies have been introduced in 15 states, few of these bills have been enacted and signed into law. Maryland, Virginia and Georgia are three states that have chaptered laws beefing up standards and oversight. Many of these bills languish or died in committee; in Maine, the governor vetoed legislation unanimously supported in committee. Maybe these bills will get another look when the insurance industry starts putting pressure on legislators and governors; Harvard Pilgrim is making it harder to get reimbursed for compounded drugs.
Fortunately state action is not limited to passing new laws. Read this article in Politico, which discusses the aggressive activity of the Iowa pharmacy board reaching outside that state to inspect compounding pharmacies across the country. New Jersey's attorney general recently hired pharmaceutical experts to help in its investigation of the compounding industry, according to the Star Ledger.
The NCSL database is a useful, though somewhat out of date summary of state action (last updated April 15).
As NCSL points out, some of the issues addressed in the state bills include clarifying which compounded drug orders meet the state-regulated standard and which cross into a manufacturing regulatory category; updating definitions for compounding, wholesale, specialty and hospital-based pharmacies, and clear language about "sterile" and "non-sterile" compounding; inspection of facilities; enforcement responsibilities; funding; and transparency of records.
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Pharmaceutical Prices and Patents Impacted by Trade Policy
The federal government is currently negotiating two trade deals that could have great significance for drug pricing. Negotiations for the Trans-Pacific Partnership (TPP) have been ongoing for several years and the Obama Administration is seeking to wrap up the 11-country deal by the end of 2013. While the agreed-to text of the TPP is secret, leaked negotiating offers and past experience with similar treaties with Australia and Korea, as well as recent cases under NAFTA, raise big concerns.
The TPP as well as the Trans-Atlantic partnership, which begins negotiations next month, will likely contain provisions that would empower foreign pharmaceutical corporations to directly attack our domestic patent and drug-pricing laws in foreign tribunals. Already under NAFTA, which does not contain the new rules proposed for TPP, drug firm Eli Lilly has launched such a case against Canada, demanding $100 million for the government's enforcement of its own patent standards - see Fact sheet on NAFTA patent case. In Australia, where a trade agreement similar to what is proposed in the TPP has regulated drug pricing for several years, a recent report shows price hikes as a result. Read more on Australia's experience and the public health community's concerns about the TPP here. Closer to home, the Maine Citizen Trade Policy Commission's 2012 assessment of trade impacts focussed on the potential that the TPP would increase drug prices generally and limit the operation of state Medicaid and other programs that negotiate or set reference prices. See also NLARx Executive Director Sharon Treat's analysis of the leaked text and its implications for state medicaid programs.
What can state legislators do? Get involved! Call your members of Congress and ask if they have reviewed the TPP text and understand the implications. Likely, they have not as the text is kept under wraps and only recently has at least one member - Congressman Alan Grayson - been able to read it. Here is a resolution adopted by NLARx in 2011 on trade and pharmaceutical policy; it remains relevant and could be a model for resolutions in state legislatures. |
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For up-to-the-minute posting of news of interest and events, become a fan of NLARx on Facebook here and follow us on twitter here. |
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