Out-of-Control Specialty and Oral Cancer Drugs Get Legislators' Attention

Here's a report everyone should read: "Clear Evidence Of US Specialty Drug Price Collusion Ignored For Years," a study of specialty drug prices and PBMs. State legislators have focussed on specialty drug issues in several ways. Maryland House bill 736

requires the State Board of Pharmacy to specify the prescription drugs that may be considered specialty drugs by a PBM, which would be prohibited from requiring a specialty drug to be dispensed by mail order and must instead allow any licensed pharmacy or pharmacist to fill a prescription for a specialty drug if the pharmacy or pharmacist meets specified requirements.

More typical are bills to require insurance coverage of oral cancer drugs. Legislatures in 19 states and the District of Columbia enacted such "parity" laws in 2012, and this trend has continued in 2013. Massachusetts recently enacted this legislation, SB 2363, signed into law by Governor Patrick over the objections of business groups concerned about treatment costs of as much as $115,000 per patient per year. LD 627, still in committee in Maine, is typical of bills being introduced across the country.

States Address Compounding Pharmacies

The National Conference of State Legislatures has put together a handy summary of state action on compounding pharmacies in 2013, as well as a compendium of existing laws and other resources on the issue. According to NCSL, as of March 10, 2013 there have been 16 bills related to the regulation of compounding pharmaceuticals proposed in 11 states.

Virginia's legislation and Utah's legislation has passed through committee and been sent to their respective Governors. House Bill 3161 and senate bill 183 are similar and pending in South Carolina; you can research S. Carolina bill status here. Bills are also pending in California, and the Massachusetts House and Senate. Three bills are pending in Minnesota, and House and Senate bills are in committee in New Jersey. The New Hampshire bill has been reported positively out of committee in amended form, and the Oklahoma bill has passed the House and been sent to the Senate. Maine's legislation will be printed next week. Mississippi's legislation died in committee and Hawaii's legislation may also not be enacted according to this database.

Compounding pharmacies, unfortunately, continue to be in the news; last week the FDA warned of another recall, this time of Avastin compounded by a Georgia pharmacy, reported here.

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.

For more information:

Sharon Anglin Treat, Executive Director
207-622-5597
streat@reducedrugprices.org

www.reducedrugprices.org

Featured Book: Pharmageddon

In the December issue of Health Affairs, the leading US policy journal, Don Light reviews the new book by David Healy, Pharmageddon.

---

As a practicing psychiatrist and leading authority on pharmaceutical policy, Healy has published several books on how the dependency of researchers, regulators, and physicians on pharmaceutical funding has distorted diagnosis, drug development and treatment. (See for example The Antidepressant Era. Harvard University Press, 1997)

Light considers Healy's book as "the most powerful and deeply thought of a new crop of books on pharmaceuticals and medicine." For example, Healy describes how pharmaceutical companies co-opted randomized clinical trials that promised to make drug development more scientific. His account of how Abbott transformed the rare condition of manic depression (MD) into "bipolar disorder" that is alleged to affect 5,000 times more people per million is worth the price of admission. He gives specific examples of how companies have hidden harmful side effects from view. He shows how the FDA's decision to make many more drugs "by prescription only" has distorted the physician's role and turned most physicians into marketing agents. Good researchers and clinicians end up doing bad things to patients. READ MORE

More on Compounding Pharmacies

Obviously there is a lot going on in response to the 39 deaths and over 600 cases of meningitis and other injuries caused by contaminated compounded drugs sold by a Massachusetts pharmacy. The FDA has acknowledged its regulations are inadequate and a recent report issued by Massachusetts Congressman Ed Markey outlines initial concerns with both state and federal oversight. The FDA recently held a daylong meeting with state regulators to discuss the role of states and the federal government going forward. 

At the state level, the Council of State Governments (CSG) plans a webinar for this Thursday, January 3 titled "The Meningitis Outbreak and the Regulation of Compounding Companies: Federal and State Roles." The National Conference of State Legislators (NCSL) has compiled a database of state laws and regulations, as well as an initial report on actions under way in some states. The International Academy of Compounding Pharmacists (IACP) has its own recommendations for state regulatory action.

There is no question that state legislators, as well as pharmacy boards and public health agencies will be looking hard at compounding pharmacy regulations and the role of their states in assuring patient safety, and we will be reporting on their actions in the weeks and months ahead.

Outrage of the Year:

Questcor Finds Profits, at $28,000 a Vial
NY Times, December 30, 2012
Read the article

Thanks to Andy Pollack of the NY Times for continuing to shine a light on some of the most outrageous practices of the pharmaceutical industry, aided and abetted by backwards R&D incentives, patient-harming patent policies and industry gaming of marketing rules.

The sad thing is, instead of a major effort to change these incentives and policies, we see the federal courts enshrining and protecting commercial free speech to such an extent that it threatens public health and safety by weakening rules preventing off-label marketing, and we see our international trade negotiators extending the reach of flawed intellectual property and drug pricing policies so that in the future, Big Pharma won't even have to go to the courts to keep a lock on outrageously high prices - they will just take their case to an international arbitration panel as is being done right now by Lilly in a case brought under NAFTA.  State legislators do what they can but are often knocked back by legal decisions that limit their policy actions.

Indeed, the current strategy of the industry, abetted by corporate-funded policy outfits such as ALEC and the Heartland Institute, is to go after states with the temerity to regulate, say, personal and prescriber privacy in datamining, by seeking huge payouts in attorneys fees, with those judgments then used to personally attack legislators and AGs who champion such initiatives. That's what happened in Vermont and Maine this past election season, and these actions send a clear and chilling message to state policymakers: watch out, or Big Pharma will take you down. While neither Vermont AG Bill Sorrell nor Maine Representative Sharon Treat lost their elections in this case, surely legislators will be increasingly reluctant to address emerging public policy issues with this recent history as guidance.  Big Pharma already has a huge role in funding election campaigns, and all that campaign cash clearly has an effect both in Washington and at the state level in limiting the zeal with which legislators tackle issues the industry would rather remain unaddressed.

From the Director:

Best wishes to everyone for good things in the New Year, 2013. We are looking forward to newly elected state legislatures in most of the country starting this week. While many issues stay the same from year to year, we also expect action, or at least legislation to be introduced, in some new prescription drug policy areas. I recently surveyed legislators to find out their priorities, and while I am still receiving feedback, it looks like regulation of compounding pharmacies is first on many legislators' to-do lists. Send your feedback to info@reducedrugprices.org

Another issue legislators will definitely continue to tackle is opiate addiction prevent strategies, including the emerging issue of the release of patent restrictions on Oxycontin and Opana, such that new, cheaper, generic versions will not be required to also incorporate the ant-diversion technology the brand manufacturers implemented.

Expect legislators to continue to address concerns about over-prescribing of psychiatric drugs to children, and the sometimes related problem of conflicts of interest caused when medical doctors, some in positions of authority implementing state pharmaceutical policy, are also on industry payrolls.

Other hot-button issues are likely to include how the prescription drug provisions are implemented in the Affordable Care Act, as determined by essential benefits and mental health parity decisions, and the intersection of electronic medical records with privacy concerns. At least one state will be addressing legislation to allow state employees and private sector businesses to purchase prescription drugs from Canada and other countries.

Prescription drug prices and overall pharmaceutical costs continue to motivate many state legislators to take action. In one day right before Christmas, 20 legislators signed a national letter we circulated calling on President Obama and Congress to achieve fiscal cliff savings by negotiating drug prices, not cutting health care. Read the letter.

Legislators seem to be fighting a losing battle in their efforts to reduce drug prices and tackle some of the most important pharmaceutical policy issues directly impacting the health and safety of their constituents. For our editorial on this, read our Outrage of the Year commentary in our newsletter.

In any event, over the next year you can count on us to provide you with the latest information on what state legislators are working on in the 2013 legislative session related to pharmaceutical policy. For the most up-to-date news, be sure to follow us on Twitter (@nlarx) and Facebook.  We also regularly post news stories and links to reports and testimony on our website you can also sign up for our newsletter.

2013 Agenda: Implementing the Prescription Drug Provisions of the Affordable Care Act

• Medicaid rebates can and should be improved. The Affordable Care Act changes how Medicaid rebates are administered, and one outcome could be better oversight of drug industry rebate calculation and payment. The current system is rife with fraud, and the lack of a national database of drug prices has made it difficult for states to negotiate uniform pricing. The Affordable Care Act changes the way rebates must be calculated at both the state and federal levels, increasing the amount of rebates for some drugs and establishing through regulation a national price list from which rebates can be calculated.

• Implementing the Affordable Care Act provides states with new levers to promote a variety of prescription drug policies. "Obamacare" includes a variety of provisions relating to pharmaceutical policy, including Medicaid drug pricing and reimbursement, benefit management and marketing. There are potentially opportunities for legislators to expand some existing state programs and look for alternative ways to implement other policies such as pharmacy benefit manager (PBM) transparency, disclosure of gifts and payments to physicians, datamining, academic detailing and more. States get to set the rules for the insurance exchanges and the federal government is promoting state flexibility, so states should investigate opportunities to promote better prescribing and pharmacy benefit practices.

See Also:

Planning a State Legislative Agenda for 2013 | more