States Again Look at Importing Drugs

Maine legislators have enacted significant legislation authorizing the importation of prescription drugs from several English-speaking countries.  The legislation goes into effect 90 days after the end of the legislative session, which is anticipated to conclude by October 10. The legislation was championed by a bipartisan group of legislators on behalf of both private and public employers that had operated mail-order importation programs until halted last summer by the previous Attorney General. With strong support from legislators on both the right and left, and the pro-local business flavor attached to this legislation, despite expressing reservations through his staff, Governor LePage allowed the bill to become law without his signature. This Pharmalot post provides some context and additional information about the Maine legislation. Learn more about drug importation, including online imports, at RxRights.org.
Link to the law

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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For more information:

Sharon Anglin Treat, Executive Director

207-622-5597

streat@reducedrugprices.org  

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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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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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