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Archive for the ‘health reform’ Category

Anti-fraud efforts by Attorneys-General and the Department of Justice are reaping billions more than expected

Friday, May 25th, 2012

The Affordable Care Act created some desperately needed means to start controlling ever-rising health care costs. Many — like preventive care or delivery reforms — will take some time to realize savings. In contrast, new anti-fraud efforts look to be paying off right away, in amounts much bigger than expected.

The health reform law provided $350 million over ten years to increase anti-fraud investigation and enforcement resources for the Department of Justice (DOJ) and State Attorneys-General. The goal? Saving $6.4 billion over the next decade. Given that some estimate that fraud and waste cost as much as $60 billion a year, or $600 billion over a decade, saving one percent of that amount seems a pretty modest impact.

But wait! New estimates project that current or pending settlements of drug fraud litigation by the DOJ and the Attorneys-General will top $8 billion in FY2012 alone, according to the group Taxpayers Against Fraud. (See their list below.) This is not the culmination of hundreds of lawsuits; it’s just the eight biggest. So it looks like this anti-fraud effort under the ACA will meet and then surpass this ten-year goal in less than two years!

To be fair, some of these fraud investigations were undoubtedly underway before the increased funding for anti-fraud efforts reached the DOJ and State Attorneys-General offices. But there is little doubt that providing these over-worked regulators with increased resources was a big help in increasing enforcement. DOJ probably has fewer lawyers working on all their pending drug fraud cases than some of the biggest drugmakers hire to defend in just one lawsuit. But despite these disparities, the results show that very modest government investment in fighting fraud, coupled with hard work by government lawyers and whistleblowers, can pay off big.

For example, earlier this week drugmaker Abbott Labs in Chicago settled a civil and criminal investigation of their illegal promotion of the anti-convulsant drug Depakote as an unapproved treatment of dementia in seniors, and of various conditions in children. Abbott pleaded guilty to promoting these unapproved, or ‘off-label’ uses of Depakote, and agreed to pay $1.6 billion – one of the biggest settlements for the illegal promotion of a single drug.

There could be a couple hundred pending whistle-blower lawsuits that are filed under seal and being investigated now by the federal or state regulators. These pending lawsuits may add up to billions of dollars of additional settlements.

Some critics have warned that even billion-dollar fines are an inadequate deterrent when a drug company can profit far more on illegal sales of a drug.

For instance, the $1.2 billion record-breaking settlement with Eli Lilly in 2009 for illegal promotion of their antipsychotic drug Zeprexa was less than 5 percent of Lilly’s gross sales. Yet eight months later, DOJ shattered this record with an even bigger $2.3 billion settlement with Pfizer, which amounted to 14 percent of their gross sales of eight illegally marketed drugs.

Similarly, this month’s $1.6 billion Depakote settlement is nearly 12 percent of the drug’s $13.8 billion in gross sales revenue from 1998 to 2008. Furthermore, DOJ is pioneering two mechanisms to deter future illegal conduct by Abbott, along with this hefty fine.

First, the Depakote settlement places Abbott on probation and imposes a corporate compliance and monitoring program, for five years. If Abbott violates the compliance agreement or significantly violates the law, the government can exclude Abbott, and all their drug products, from federal health care programs. That would cost Abbott billions in lost sales on numerous drugs.

The settlement also aims to hold Abbott’s corporate leadership accountable. Abbott’s CEO must personally certify compliance and the board of directors must review and report on compliance each year. If the CEO or board is lax in these duties, they could be excluded from their positions at Abbott. And if they intentionally lie to the government to cover up any misconduct, they could face personal criminal liability under the federal False Statements Statute.

Sadly, Abbott’s illegal promotion of ineffective and dangerous uses of Depakote has both harmed and put at risk what is arguably the most vulnerable patient population – seniors suffering from dementia, who live away from their families in nursing homes. Undoubtedly millions of seniors were and continue to be given Depakote inappropriately as a result of Abbott’s illegal promotional campaign.

More to come on (1) actions that Medicare and Medicaid can take to address the continuing effects on patients of illegal promotions of off-label use of drugs and (2) how the Arkansas AG fought prescription drug fraud, winning huge fines to plug the state’s Medicaid budget deficit. This blog was also posted on Health Policy Hub.

– Wells Wilkinson, Director, Prescription Access Litigation
Staff Attorney, Community Catalyst

Projected Drug Fraud Settlements in FY 2012

Manufacturer Settlement($,millions) Fraudulent conduct
Merck: 950 Off-label marketing of Vioxx — settled
GlaxoSmithKline: 3,000 Series of drug frauds, said to be settled in principle
Abbott: 1,500 Off-label marketing of Depakote, settled
Amgen: 780 illegal marketing of Aranesp, funds reserved.
Pfizer: 500 Illegal marketing of protonix, projected settlement amount
Johnson & Johnson: 1,000 Off-label marketing of Risperdal, civil settlement is expected.
Ranbaxy: 400 adulteration of HIV drugs, settlement in excess of $400 million expected
Sandoz (Novartis): 150 AWP pricing fraud, settled
TOTAL 8,280

 


Sunshine Now on the Horizon

Friday, December 16th, 2011

Yesterday, CMS started to make up for lost time when it issued the draft regulations on the Sunshine law in the Affordable Care Act. This new law requires manufacturers of drugs, medical devices (e.g. stents, replacement knees etc), and biologics to report all payments they make to doctors and teaching hospitals to HHS, which must disclose these payments in a publicly available, on-line searchable database.

In response, Senators Grassley and Kohl cancelled a hearing to explore why CMS had missed an earlier deadline and thus delayed the start of the new transparency program. This was of concern to both consumer advocates eager that these payments become public, and to industry representatives who are concerned about how to comply with the transparency law starting next year.

The delayed release of the new draft rules does mean that industry will not have to record or report payments that are made before the final version of the rule enters into effect, likely no earlier than April or May of next year. CMS is accepting public comment on the draft rules until Feb. 17, 2012. But CMS is standing by the law’s required September, 2013 deadline for disclosing to the public any 2012 payments that are made after the rule is final.

While we are disappointed that the first public transparency reports may not have a full year’s data, we think it is more important to allow CMS adequate time to ensure that the final regulations are as strong and effective as possible. From our point of view, good regulations will help ensure that industry reports payments fully and precisely, so that patients, the public and CMS itself can best understand what these payments are for, and evaluate whether a payment is appropriate.

One highlight of the draft rule was how CMS captured the purpose of the law’s new public transparency program. CMS states that, while industry collaboration can be beneficial, “payments to physicians and teaching hospitals can also introduce conflicts of interest that may influence research, education and clinical decision making in ways that compromise clinical integrity and patient care, and may lead to increased health care costs.”

The on-line database of industry payments, to be made publicly available by Sept. 30, 2013, will include the name and identifying information for the manufacturer making the payment, the doctor or teaching hospital receiving it, the amount of each payment, the drug or device associated with the payment or “transfer of value”, and the form and “nature” of the payment. We were pleased that CMS proposed broadly inclusive definitions of manufacturers, their subsidiaries, and third parties who may make payments on their behalf, although CMS has asked for comment on this definition.

The draft rule also proposed that the categories of payments should be distinct from one another to ensure the utility of the information to patients, to researchers and the public. However, we do have concerns that the final rule will not honor that intent if it does not provide clear definitions on how the categories (such as education, gifts, consulting, etc.) differ from one another. The draft rule as it stands now leaves out clear and specific definitions, which would open the door to varying interpretations by each company, a problem we have already seen in the public disclosures required under court settlements. This results in data that is inconsistent, confusing, and not useful to the public.

Overall the CMS framework is solid and reflects the spirit and intent of the Sunshine law, which was supported not only by consumers but by leaders in the medical profession, the Institute of Medicine, MedPac, and many in industry.

The draft regulations include many thoughtful discussions of reporting issues and invite further comment on many of them— a clear opportunity for consumer advocates concerned about the drug industry’s abuse of financial incentives to doctors or teaching hospitals. We will be submitting our recommendations to address this issue and hope others will as well.

– Marcia Hams, Director of Prescription Access and Quality &
Wells Wilkinson, Staff Attorney

Where’s the Sunshine?

Monday, November 7th, 2011

Things are getting colder here in New England, and we’d been hoping for a little more Sunshine in October. That’s when HHS was supposed to issue rules implementing the Physician Payment Sunshine provisions of health reform.

The urgency was summed up by co-sponsor Sen. Chuck Grassley (R-Iowa) back in 2009: “Transparency fosters accountability, and the public has a right to know about financial relationships. Patients rely on their doctors’ advice. Taxpayers spend billions every year on prescription drugs and medical devices through Medicare and Medicaid. They also fund tens of billions of dollars of medical research each year, and the doctors conducting that research have a big influence on the practice of medicine.” For the last several months, Senators Grassley and Kohl (D-Wisconsin) have been urging HHS to issue regulations as quickly as possible to meet this need.

The Sunshine provisions require drug, device, biologics and medical supply makers to start submitting information to HHS on their payments to physicians, teaching hospitals and group purchasing organizations (GPOs) this January. That information must be available to the public on September 30, 2013 through a searchable online database.

We are increasingly worried that HHS delays could interfere with the process of collecting the most accurate, consistent and understandable reports from manufacturers, and that we and other interested parties will not have time to weigh in on the reporting framework that HHS proposes. Because of these concerns, we submitted a letter on October 20 to HHS Secretary Sebelius, along with Consumers Union, the Pew Health Group and industry itself – PhRMA, BIO and AdvaMed.

Early this spring, Community Catalyst shared our informal recommendations with HHS on how the systems could be set up to be most effective. We based our thinking on our experience with state disclosure laws and industry disclosures resulting from lawsuits and government investigations. Our top concerns are that:

  • Reporting categories be defined in a specific, unambiguous, and mutually exclusive manner, so that data tells a clear picture of what these financial relationships are
  • The public disclosure website be useful to all users, including lay consumers, physicians whose payments are being reported, and researchers interested in studying trends and impacts of financial relationships with industry

The Sunshine statute itself is much more specific than the state disclosure laws that it will replace. (Note: states can still collect other information not required by Sunshine, such as payments to nurse practitioners.) For instance, the Sunshine provisions lay out 14 descriptors for the “nature” of a payment, including, in brief: consulting fee; compensation other than consulting; honoraria; gift; entertainment; food; travel; education; research; charitable contribution; grant; royalty or license; ownership interest; and speaking for serving as faculty. States and industry data bases use many fewer, often ambiguous categories.

However, we have urged HHS to refine these definitions in regulation so that there is no confusion over how a company should report its payments. And physicians and teaching hospitals deserve to have the payment categories carefully described so they aren’t misinterpreted. The public needs clarity to assess whether certain payments might or might not affect the care they are receiving.

There are concerns by some over how the Sunshine disclosures will relate to other public sources of information on industry payments. These types of issues were front and center last week at a conference we attended on conflicts of interest, put on by the American Society of Law, Medicine and Ethics. The Sunshine law requires industry to report their payments to physicians and teaching hospitals, but physicians themselves must make disclosures about their industry financial ties to many sources, including academic medical centers, medical journals, NIH and FDA panels. There is the potential for confusion and misinterpretation of the data. Despite the challenges, Robert Steinbrook, MD from Dartmouth, and former deputy editor of NEJM, concluded in his presentation on COI and medical journals, that with the Sunshine provisions, “there should be additional opportunities to better control conflicts of interest in Medicine.”

Indeed, we believe the Sunshine provisions can set a national standard that will help in harmonizing all disclosure requirements and provide a useful cross check for physician self-reports.

– Marcia Hams, Director, Prescription Access and Quality
Community Catalyst

Senators Grassley and Kohl Keep Up the Good Fight

Thursday, October 13th, 2011

Senators Charles Grassley and Herb Kohl are two of the legislative champions of the Physicians Payment Sunshine Act, which was included in the Affordable Care Act (ACA) last year. They recently sent a letter to the Centers for Medicare and Medicaid Services (CMS), expressing “severe disappointment” about a major missed deadline that puts timely implementation of the legislation at risk.

We at PostScript join in their disappointment that regulations on the Sunshine Act have not yet been released by the CMS. We also appreciate the attention the Senators’ letter gives to the role for consumers and consumer advocates – these rules are ultimately for the benefit of health care consumers. We have a personal stake in knowing our physician’s potential conflicts of interest because payments from industry may affect decisions they make about our care, the affordability of our treatment and ultimately of our insurance premiums.

A Minneapolis Star Tribune editorial said it well:

“Some might be tempted to applaud the delay of any new industry regulations. That’s shortsighted. The Sunshine Act will require public disclosure of the large sums sometimes paid to medical professionals by industry. That collaboration is important for medical innovation, but there are also concerns about whether money influences doctors when it comes time to choose between new products and older drugs or devices. Payment information should be easily accessible so that patients can weigh for themselves if medical providers have their best interests at heart.”

To date, the independent, non-profit newsroom ProPublica has done their share to get the ball rolling. Combining industry disclosures required by Department of Justice lawsuits concerning illegal marketing (Pfizer, Novartis, Eli Lilly, Johnson & Johnson, etc), ProPublica has created an online database of payments to doctors from the 12 companies whose “combined prescription drug sales amounted to about 40 percent of the U.S. market in 2010.”

ProPublica has also helped journalists understand and publicize the importance of these payments through an ongoing series of news articles about industry payments to doctors. But as ProPublica notes, “physician payments from potentially hundreds of drug and device companies operating in the United States are still secret for the time being.” The Sunshine Act will not only provide transparency of payments by all companies, but make disclosures more detailed and consistent.

In April, CMS hosted an open door meeting by phone, where industry and consumers weighed-in on some important definitions that the Department of Health and Human Services (HHS) must clarify through regulation. For instance, how will industry draw the line between education and marketing? What kinds of research payments can be delayed, and which can’t? How the agency defines certain types of payments will have real impacts upon how the data is reported, and how useful it will be to consumers and others researching the effects of these payments. So the agency has its hands full.

Community Catalyst knows from our other work on many aspects of the ACA that HHS and CMS have their hands full implementing the biggest expansion in health care coverage and other improvements to the U.S. health care system in more than forty years. However, the Sunshine Act rules also need to come out soon, so the industry has ample time to implement systems to track all their payments starting January 1, 2012.

Here is a refresher on the timing of the Sunshine Act provisions:

  • Spring/Summer 2011: The Secretary of Health and Human Services was “required to consult with the Inspector General, affected industry, consumers, consumer advocates and other interested parties to ensure that the information made available to the public is presented in the appropriate context.”
  • October 1, 2011: Deadline for regulations that establish the procedures for applicable manufacturers to submit information, as well as procedures for making such information available to the public.
  • January 1, 2012: Manufacturers begin collecting data for calendar year 2012. Duplicative state laws preempted (see Pew Prescription Project fact sheet).
  • March 31, 2013: Manufacturers submit information to CMS on payments for calendar year 2012.
  • April 1, 2013: Report to Congress on information collected from industry.
  • August 16, 2013: Manufacturers and recipients have opportunity to review and correct posting prior to publication of the data, subject to subsection (c)(1)(D). Review period under (c)(1)(C)(ix) – cannot delay posting date.
  • September 30, 2013: CMS to publish information on public, searchable website, and to send their first reports to states.

More about Sunshine? Check out the Sunshine Act Guide.

– Anna Dunbar-Hester, Program Associate and
Wells Wilkinson, Director Prescription Access Litigation

What do patients want? And why it matters for Sunshine

Wednesday, May 5th, 2010

Roughly two-thirds of patients believe it’s important to know a physician’s ties to a pharmaceutical company, and between 27 percent and 56 percent believe that such ties affect prescribing. Those are some of the findings from a systematic review in the current Archives of Internal Medicine that looked at 20 surveys of patients, research participants and medical journal readers about the impact of financial ties physicians and researchers have with the pharmaceutical industry.

That two-thirds finding – and a study last year suggests that number may be much higher (84 percent wanted their physicians to disclose relevant financial ties to them) – syncs up with the findings of a 2008 nationwide survey (pdf) we conducted: 64 percent felt that it was important to know if their doctor had a relationship with a drug companies. But less than half said they would be likely to ask their doctors about this.

That makes sense. Setting aside the mores around talking about money and mystique associated with the medical profession, the doctor-patient relationship is characterized by an inherent power imbalance: the sick come before one who understands and can treat their condition. So it’s unsurprising that patients are hesitant to ask their doctor whether he or she did a lunch and learn for Lipitor last month.

That’s one reason the Physician Payments Sunshine Act, which passed with national health reform, is so important. The Sunshine Act, which will create a national public website into which drug and device companies must report payments and gifts made to physicians, will allow consumers to access the information they and much of the medical community have deemed relevant to clinical care—without requiring them to obtain it in by asking cold in the exam room.

The authors of the Archives study made this Sunshine connection, highlighting the significance of their findings for those charged with designing and implementing the disclosure database:

[W]e find that, across multiple studies, patients and research participants are able to distinguish between different types of [Financial Ties] as well as the relative importance of disclosure of each. Public reporting systems should be designed to maximize consumer understanding, with an emphasis on clear and straightforward presentation of those FTs that stakeholders care most about.

That’s right.  But that doesn’t mean it will be easy. As we’ve pointed out here, much-touted voluntary (and often court-ordered) company disclosure data has been hard for researchers and the public to navigate or extract—and each company system is marked by unique loopholes that limit the usefulness of the data.

In an accompanying editorial (subscription required), Eric Campbell, a Harvard researcher who has written extensively on physician-industry relations and served on the Institute of Medicine committee that produced last year’s conflict-of-interest report, wrote:

In order for consumers to use the data, it is clear that the quality of the data that is reported by companies must be improved. The early experiences from Minnesota and Vermont, which have the longest history of making physician-industry relationship data available, suggest that the details are important in making this information useful.

Campbell says that means establishing real auditing capabilities, meaningful penalties for non-compliance, and adequate funding to support data collection and reporting.

–Kate Petersen, PostScript blogger

927

Tuesday, March 23rd, 2010

It’s been 927 days (back of our envelope, anyways) since Senators Charles Grassley and Herb Kohl first introduced the Physician Payments Sunshine Act, a bill that would require drug and device companies to disclose on a public, searchable website the gifts and payments they make to physicians and teaching hospitals. (Postscript is younger by a few weeks.)

Today, the Sunshine Act became law, as a provision in the national health care reform bill signed by President Obama. You can read the final provisions here.

Though it has not captured headlines like the coverage provisions and insurance regulations in the reform bill have, today’s passage of the Sunshine act is itself a dramatic answer to years of growing questions about how to balance the need for industry to work with academic researchers and the need to keep patients safe with good prescribing that is free from the influence of marketing. In recent years, that line has often proved a blurry one, as a series of investigations and media reports revealed that physicians have received millions of undisclosed dollars in speaking and advisory roles for drug companies, even as they conducted research on drugs made by those companies. PostScript has been along for much of that ride (as the archives in the right rail attest).

The momentum for Sunshine has come from a lot of corners – the investigations and hearings, led by Sens. Kohl and Grassley, that brought to light some of the most dramatic conflicts-of-interest between marketing and medicine.

It has come from many Members of Congress, who co-sponsored, worked on and advocated for Sunshine over the years.

It has come from academic medical centers and professional medical associations, who took a look at their own relationships with industry and developed policies to clarify those relationships.

It has come from the AMSA Scorecard, a joint project of the American Medical Student Association, Community Catalyst and the Pew Prescription Project  to rank the conflict-of-interest policies at every medical school in the nation.

It has come from state lawmakers and regulators, who brought bills and rules aimed to better safeguard prescribing from the influence of marketing dollars.

It has come from the efforts of numerous groups, including ours here at Community Catalyst and at the Pew Prescription Project.

It has come from the broad-based National Coalition for Appropriate Prescribing, which helped remind Congress why transparency is so important for consumers.

And it has come from pharmaceutical and medical device companies, many of whom acknowledged, in revised conduct codes and voluntary disclosure measures, that gifts don’t have a place in the doctor’s office.

We are proud of this collective effort, and all the work that went into getting Sunshine on the books. Thank you.

–Kate Petersen, PostScript blogger

Sunshine rules, Rx “doughnut hole” in White House health care bill

Monday, February 22nd, 2010

In his health care reform proposal to Congress and the nation revealed today, President Obama has included requirements for pharmaceutical and medical device companies to disclose payments to health care providers and hospitals. These ‘Sunshine provisions,’ modeled after a bill introduced in the Senate in 2007 by Senators Herb Kohl and Charles Grassley, have bipartisan, bicameral support, and were included in the health care reform bills passed by both the House and Senate this winter.

Here’s the language:

To prevent conflicts of interests and insure full transparency and information for patients, the Act requires all drug companies, device, and medical supply manufacturers to fully disclose and report any gifts they make or financial arrangements they have with doctors, a physician practice or group.

The proposal, released ahead of a much-awaited bipartisan health care reform summit at Blair House this week, reflects a growing national consensus about the need for robust transparency of the financial relationships between providers and the pharmaceutical and device industries, including recommendations by the Institute of Medicine and the Medicare Payment Advisory Commission.

The President’s health care reform proposal also requires pharmacy benefit managers to disclose information about negotations and drug pricing deals they make, a component of the original House bill passed in November.

President Obama’s proposal goes beyond the Senate bill on prescription drugs in two other important ways:  closing the Medicare Part-D ‘doughnut hole,’ and banning pay-for-delay settlements that keep drug costs artificially high.

By closing the doughnut hole, the President’s plan would save the 8 million seniors who exhaust their prescription drug benefits each year an average of $4,080 a year by 2020. Like today, seniors will still have a 25 percent co-insurance obligation until ‘catastrophic’ coverage kicks in, unless they qualify for low-income subsidized coverage.

The proposal also grants the Federal Trade Commission the authority to police drug company patent settlements for “collusion” to keep generics off the market. FTC estimated that such a reform would save $35 billion over the next decade, and Obama’s proposal would give FTC the authority to prevent these settlements unless proven to increase competition.

–Kate Petersen, PostScript blogger

CME part and parcel of transparency

Monday, November 16th, 2009

Will CME providers be included in the Sunshine provisions of health care reform? The Wall Street Journal looked at the question recently. The final House health reform bill includes CME providers and other third-party medical groups among the covered recipients whose payments from the pharmaceutical and medical device industry would be publicly disclosed—language referred to as the Physician Payments Sunshine provisions. The Senate Finance bill that is being merged now with the HELP committee  also contained Sunshine provisions, but did not include third-party groups.

Yet representatives of industry-backed CME in Washington whom the Journal spoke to seem to understand that good transparency means broad transparency, and that broad transparency is becoming a requisite for credibility in the medical education industry.

Indeed, since the Sunshine Act was introduced in January 2009 as a stand-alone bill that would require drug and device companies to disclose all payments to doctors and others, acknowledgment of a need for national medical transparency standards has gained wide acceptance. The Institute of Medicine and the Medicare Payment Advisory Commission have both recommended that third-party medical groups like CME providers be among those whose payments from industry should be disclosed; the IOM called for an end to all company support of such education programs within two years. As the Journal points out, companies such as Pfizer and GlaxoSmithKline have stopped direct support of for-profit third-party CME providers.


–Kate Petersen, PostScript blogger

Rx Futures

Tuesday, November 18th, 2008

In the afterglow (or for some, aftermath) of the election, PostScript thought it was worth scanning the federal policy horizon for any Rx out there.

And it’s hard to say anything about prescription drug policy in the next Congress without first talking about health reform.

With an early break from the gate, Senate Finance Committee Chair Max Baucus (D-MT) released a white paper last week entitled “Call to Action: Health Reform 2009.” The paper was the first look at an issue that lawmakers and President-elect Obama have both named as a priority when Congress reconvenes. It included provisions for comparative effectiveness, coverage-guarantee for those with pre-existing conditions, and would allow people age 55-64 to buy into Medicare early.

While passing health care reform is going to take broad consensus, and others such as Sen. Edward Kennedy (D-MA) and President-elect Obama are working on comprehensive plans of their own, we were encouraged to see that the Baucus paper recommends public disclosure of the financial relationships between industry and the medical profession. The paper referenced the recommendations MedPAC approved last week (see our earlier post) as well as S.2029, the Physician Payments Sunshine Act, though it doesn’t recommend specific reporting thresholds as MedPAC and PPSA have.

And right after Who Will Be the Next Commish, a little game being played at all the right blogs and Beltway dinner parties this season, we see two major FDA questions facing the Congress in its next term:

Q: With drugs coming from everywhere on the planet, how do we make sure they are safe enough to go into American medicine cabinets?

(Probable) A: The FDA Globalization Act. Ever since the heparin-from-China scare of 2008, interest in having a better handle on where our drugs are coming from and a bill that would shore up oversight, require new country-of-origin labeling, provide more resources for inspections of foreign manufacturing plants, and grant the agency subpoena power many other federal agencies charged with protecting the public already have. Both a House and Senate version were introduced in 2008.

Q: What happens to biotech drugs after the patent runs out?

(Right now) A: Nothing, and that’s an expensive answer both for consumers and the future of the drug pipeline, as R&D turns more and more to biologic therapies. Currently, four draft bills on the creating a pathway for biogenerics (also called “follow on biologics”) are circulating. The version introduced by Rep. Henry Waxman (D-CA) is widely considered to be the most consumer-friendly.

Only 64 days till the 111th is sworn in, so stay tuned – we sure will.

Gov. Patrick signs MA cost containment bill, pharma restrictions

Monday, August 11th, 2008

Yesterday, Massachusetts Gov. Patrick signed the omnibus health cost containment bill, enacting some of the strongest pharmaceutical marketing restrictions in the country. (Press release here) The law requires drug and medical device companies to disclose payments to health care providers over $50, establishes a prescriber education program, and gives the Department of Public Health power to establish regulations at least as strong as those in the Pharmaceutical Researchers and Manufacturers of America voluntary Code, which prohibits small gifts, travel payments, and extravagant restaurant meals to doctors.

S.2863, An Act to Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality Health Care, also expands state medical school rolls to train more primary care physicians, encourages the use of electronic medical records, and establishes a hearing process for insurance companies that choose to raise premiums.

The governor weathered a heavy week of lobbying from the industry, including a full page ad in the Boston Globe threatening to leave the state if he signed the bill into law. (See our blog here.)

“I have a lot of respect for the governor, and I am proud that he did not bend to the pressure,” state Sen. Mark C.W. Montigny (D-New Bedford) told the Standard-Times. “I have never seen lobbying this intense. They have been swarming the Statehouse for weeks.”

Health Care For All, our coalition cousins in the Massachusetts Prescription Reform Coalition, cheered the signing on A Healthy Blog, reminding us that the bill is a victory not just for better pharmaceutical marketing practices in the state, but because it makes way for better health care for all. 

The passage of important checks on excessive industry marketing “shouldn’t lead us to ignore the many other provisions in the bill, from an e-health program that preserves consumer confidence to significant primary care enhancements to a directive to find a way to fundamentally restructure the payment system to promote health, rather than high-cost treatments. The statute truly is Health Reform II, and will undoubtedly be followed by further refinements in the future.”

Coverage abounds:

Boston Globe

Associated Press

Wall Street Journal Health Blog