This week, the White House unveiled several policy proposals that it would like to see included in national Health Care reform.  See white house proposals here. Significantly, the White House strengthened the Senate’s earlier health reform bill by including a number of prescription drug provisions, including:

- an immediate $250 rebate for seniors that enter the ‘donut hole’ along with a plan to close the donut hole completely by 2020. The proposal notes that “Over 8 million seniors hit this gap in Medicare coverage, and for those who do not have other coverage, average drug costs are $340 per month, or $4,080 per year.”

- a provision giving FTC the authority to challenge ‘pay-for-delay’ or reverse-payment settlements that keep generic drugs off the market.  This reform is estimated to save $35 billion over the next decade, while making generic forms of some drugs more readily available. 

Even before these White House proposal were announced, the bill passed by the Senate and pending before the House included several significant reforms concerning prescription drugs, including:

- the expansion of prescription drug coverage to some 30 million newly covered people.

 - a reform to promote needed transparency and reduce doctor’s potential conflicts of interest, through the “full transparency [of] all drug companies, device, and medical supply manufacturers . . . gifts . . . or financial arrangements” with doctors. This proposal follows the current reform in the Senate bill.

- a transparency provision to require all pharmacy benefit managers (PBMs) under Medicare or the exchange to report “information regarding any rebates, discounts, or price concessions they negotiate for prescription drugs” to help health plans reduce waste and losses caused by PBMs. And health plans would also be told how often available generic drugs are used.”

- a 50% discount off branded drugs for seniors in the donut hole.

- billions of dollars in fees on drugs and devices to help pay for this historic expansion of coverage.

Pay-for-delay legislation needed now more than ever.

Also this week, a Court dismissed an FTC and consumer challenge to the legality of a pay-for-delay settlement concerning the drug Androgel. The Court dismissed the FTC’s complaint asserting that the agreement was anti-competitive, despite the fact that the generic competitor.

An article in Today’s BNA Pharmaceutical Law and Industry Report describes the decision, including the efforts by drum maker Solvay to transfer the case from California’s Ninth Circuit, to the less-favorable 11^th Circuit. The result of the case, following the precedent set in the 11^th Circuit in Shering-Plough, is not as surprising. But comments by the Generic Pharmaceutical Association’s were. This group asserted that the FTC’s loss somehow demonstrates that the FTC’s existing authority “adequately protects consumers” and that new legislation would be “anti-consumer.”

How you can help:

Keep fighting the good fight

Yesterday’s White House summit illustrated how economic hard times and continuing insurance industry abuses leave consumers without protection without comprehensive reform.  (You can see highlight from CNN here, and Community Catalyst’s take on it here.) 

Advocates need to continue to make the case for comprehensive reform.  You can help by signing this online petition that is being sponsored by the American Cancer Society/ Cancer Action Network, Community Catalyst, and many other national organizations: www.healthcarepetition.org/10707_communitycatalyst

Prescription Access Litigation’s parent organization, Community Catalyst, is also home to The Prescription Project, which works to eliminate conflicts of interest created by pharmaceutical industry marketing by promoting policy change among academic medical centers, professional medical societies and public and private payers. Rob Restuccia, the Prescription Project’s director has an excellent op-ed in today’s Atlanta Journal-Constitution, Let public see doctors’ ties to drug companies.

Here it is:

What is the appropriate relationship between the medical profession and the drug industry? Last month, Dr. Charles Nemeroff stepped down as chair of Emory University’s psychiatry department after a Senate investigation exposed his failure to report hundreds of thousands of dollars in industry consulting and speaking fees, including payments from Glaxo-SmithKline, whose drug he was also studying using taxpayer dollars from the National Institutes of Health.

Last week in this newspaper, Emory economist Paul Rubin defended Nemeroff and accused Sen. Chuck Grassley (R-Iowa), who led the investigation, of leading a “war on pharmaceuticals” (“If politician’s war on drugs continues,” @issue, Oct. 28). Rubin argues that Nemeroff’s presence on 21 pharmaceutical payrolls is evidence that he is conflict-free, for how could he possibly favor the product of one company over the other 20? It’s a fallacy of the first order.

Physician-researchers play an important role in evaluating new drugs. But many physicians are also involved in helping the industry market its products. NIH guidelines do not prevent collaboration with industry (as Rubin suggests), but they do require that financial interests of more than $10,000 a year be reported and that conflicts of interest be managed so that publicly-funded science is not colored by industry support. Documents released by Grassley suggest that Nemeroff misled university officials about the extent of his financial relationships.

Nemeroff is in a group of influential doctors the industry refers to as “thought leaders,” prominent researchers that drug companies use to help promote their products among other physicians. A copious body of research over the past 20 years shows the link between industry marketing and physician prescribing.

The success of that marketing is at least part of the reason that U.S. doctors are so quick to adopt new and often unproven drugs. Yet news headlines warn us that new drugs —- Vioxx, Paxil, Avandia, Vytorin —- aren’t necessarily better drugs. In fact, the Food and Drug Administration’s own numbers show that in a recent five-year period, only 14 percent of drugs approved represented true therapeutic advances.

This is why there is a clear public interest in understanding the financial ties between physicians and drug companies. If disclosure of those ties discourages one physician from accepting NIH funding, there is no shortage of other highly qualified researchers who will step in to take his or her place.

Grassley understands that innovation does not stand at odds with transparency; it is strengthened by it. That’s why he and Sen. Herb Kohl (D-Wis.) have introduced the Physician Payments Sunshine Act, which would require drug and medical device companies to disclose all payments to physicians on a publicly accessible Web site, a critical step toward better, safer, more transparent medicine that Congress should pass in 2009. Patients are certainly better off for Congress’s recent efforts to shed light on conflicts of interest in medicine.

Robert Restuccia is executive director of the Prescription Project, a national initiative created with The Pew Charitable Trusts and led by Community Catalyst to ensure safe and effective drugs for consumers.

The National Coalition for Appropriate Prescribing (led by the Prescription Project - a sister organization to us here at Prescription Access Litigation) is working to pass the Physician Payments Sunshine Act, a transparency bill requiring pharmaceutical companies to publicly report their gifts and payments to doctors. The Senate version of the bill is
here and the House version is here.

Pharmaceutical and medical device industry marketing to doctors (well over $30 billion each year) takes the form of gifts, honoraria and other payments. This spending subtly and not-so-subtly induces doctors to prescribe newer and more expensive treatments, regardless of whether they’re better. This in turn drives up drug costs and puts patients at risk, because new and heavily marketed drugs are almost always more expensive, even though they are often no more effective than older, established therapies. Newer drugs may also have unknown side effects.

We believe the public deserves to know how much money individual physicians are accepting from industry. (Disclosure laws in Minnesota and Vermont reveal that many doctors receive industry payments of thousands or tens of thousands of dollars a year.) The Sunshine Act will benefit patients, payers, policy makers and taxpayers alike by creating transparency.

Key provisions include:

• Comprehensive and publicly available reporting of information down to the individual prescriber level;
• A low ($25) threshold for reporting; inclusion of all payments; and
• penalties for companies that don’t report.

Sign this petition today to ask your members of Congress to support these bills: http://www.thepetitionsite.com/1/sunshine

For more information:

• To learn more about industry payments to doctors click here
• For factsheets on the Sunshine Act House and Senate bills click here
• To see the organizations that are members of the National Coalition for Appropriate Prescribing click here

Sign the petition