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.

Community Catalyst, a national advocacy organization that builds consumer and community participation in shaping of our health system, has just launched the Generics are Powerful Medicine (GPM) campaign, a grant program to help nonprofits jumpstart creative education programs about the safety, efficacy and affordability of generic drugs. 

For more information on the GPM program, or to read the Request for Proposals, visit the Generics are Powerful Medicine website at www.genericsarepowerful.org.

When it comes to the value and power of generics drugs, the Prescription Project is the choir GPM is preaching to. PostScript talked with staff attorney Rishi Garg about the new grants and GPM’s big plan to get the word about generics out there.

PS: GPM comes out of a court settlement in a case over whether generics were illegally kept off the market. Do you think this settlement and others (the Neurontin settlement Consumer and Prescriber Grant Program) actually move the ball down the field more than if the off-labeling or buying-off hadn’t happened at all?

RG: While the creation of programs like GPM is one positive result from cases like these, everyone would much rather that pharmaceutical companies play by the rules and not stand in the way of generic competition in the first place. 

Pfizer allegedly filed frivolous patent applications and baseless patent infringement claims to keep a generic version of Neurontin off the market and maintain its billion dollar annual sales for  that drug.  Glaxo is alleged to have done many of the same things for Relafen, in the lawsuit GPM grew out of.  Both Neurontin, an anti-epileptic and Relafen, an anti-inflammatory, could have helped millions of people had it been made available as a generic earlier. 

So while consumer education programs are important, it would be best for consumers if these cases did not have to be brought.  In other words, programs like GPM are intended to cure a problem that it would be better to prevent in the first place.   

PS: Who’s your audience? Patients? Prescribers? Swing voters?

RG: Our target audience is patients, and our intent is to focus our education campaign on the uninsured or underinsured.  Low-income and minority communities are oftentimes the ones most hurt by high drug prices, the least aware of the benefits of switching to generic alternatives and yet the most likely to benefit from switching.  We hope to reach those communities. 

PS: You are starting a generics campaign in a brand-name nation.  Does your campaign have evidence that more public education about generics = increased usage? K-Mart offers Kathy Ireland blue jeans and sneakers are available cheaply at K-Mart, but women still shell out $200 plus for arguably a molecularly equivalent pair of Seven jeans, and would never think of wearing Kathy Irelands.

Setting aside safety concerns on newer drugs, is it possible that brand preference leaves less elasticity in the prescription drug market for you to work with?

RG: Perhaps, but there is a big difference between life-saving drugs and blue jeans.  A large part of the GPM campaign is dispelling myths about the quality of generics. 

People do seem to think of generic drugs as less than “the real thing.”  The challenge is to dispel that myth, and it’s a very real and large barrier.  We hope that working with medical leaders to produce accurate, consumer-friendly literature on the effectiveness of generics will help shatter some of these misconceptions.  Once the public perception changes, people will be willing to switch to generics since it will save them money, and will save the healthcare industry billions of dollars. 

PS: Following on that, what sort of outcomes are expected or tied to the GPM campaign?

RG: Our hope is that GPM becomes its own on-going self-sustaining project.  Over the next five years, numerous patents on blockbuster brand-name drugs will expire and less-costly generic  versions of those drugs will become available to millions of consumers.  A lot of education will be required so that brand-name drug companies aren’t able to fool people into continuing to purchase expensive brand name drugs in the face of less costly and equally-effective generic alternatives. 

PS: Are there any effective consumer education generic campaigns out there now that groups interested in the GPM grants might look to as models?

RG: There are a couple of consumer education campaigns, not just on generic drugs but on prescription drugs generally, that we think offer some useful models and lessons:
 
1. Blue Cross Blue Shield of Michigan tried a similar campaign to GPM a few years ago and created a great tool called “The Unadvertised Brand” at www.theunadvertisedbrand.com

2. The FDA has a great website which provides answers to common questions about generic drugs at http://www.fda.gov/cder/consumerinfo/generics_q&a.htm

3. A program out of Oregon Health and Science University compares drug effectiveness within different classes of drugs.  It can be found at http://www.ohsu.edu/drugeffectiveness/

4. Finally, Consumer Reports created a tool on their website that allows consumers to compare similar drugs and pick the most affordable at http://www.crbestbuydrugs.org/

PS:  Will you be making a GPM YouTube video?

RG: The idea of a You-Tube video has been  discussed!   Stay tuned…

Prescription drug problems have hit the presidential radar screen. With an announcement of a plan to rein in the pharmaceutical industry this weekend at a campaign stop in Laconia, NH, John Edwards became the first major 2008 presidential candidate to take on the drug companies.  Here’s coverage in the Associated Press and Concord Monitor. Check out the full Edwards platform here on the campaign website.  Though much of it’s pulled from measures stripped from the FDA reauthorization bill passed earlier this year, Edwards’ proposal, which includes provision for a comparative effectiveness drug-testing center, full disclosure of safety and comparative effectiveness information on drug labeling and ads, empowering the FDA to go after drug companies that run misleading ads, and a two year moratorium on consumer ads for new drugs, is smart, and represents a leap forward in the candidates’ health care conversation.

On one hand, the fact that pharmaceutical marketing and industry reform is showing up in the presidential platforms only now is curious.  After all, talk of health care reform is as ubiquitous on the presidential campaign trail as American flag lapel pins, and the cost of prescription drugs is an issue that has emotional resonance with a pharmacy nation like ours.  Conventional (or perhaps campaign) wisdom has led candidates to focus on coverage, access and Medicare—how to cover more people without charging anyone else—these are the big ticket items. Catch is, conflicts of interest and undue marketing influence on prescribers have the power to affect the cost of those items, and recent reports indicate that they have.

On the other hand, it’s no surprise: health care groups, pharma included, have been some of the most aggressive lobbyists and generous contributors to presidential contenders, according to the Wall Street Journal Health blog, which has done a good job of keeping track.  And today the New York Times reported that health care groups have given $6.5 million to Democratic candidates and $4.8 million to Republicans so far. 

Pfizer has been the pharmaceutical company with the deepest pockets, giving the most to Hillary Clinton ($12,150), followed by Rudy Guiliani ($8,600).  Predictably, Edwards has received the least health care sector contributions to date (the Health blog points to his career as a plaintiff’s lawyer as explanation.)

So far, the headlines have focused on Edward’s DTCA moratorium, and the Monitor piece makes clear why: On the stump, it’s easier to lampoon the endless Flomax ads during the World Series or summon, as Edwards did, goofy images of allergen-free skipping fields. That’s fine—a two-year hold on ads for new drugs certainly won’t hurt matters, and may even decelerate the dubious consumer-marketing machine pharma’s driving.

But voters and the media should remember that DTCA is just a portion of a bigger problem—companies spend nearly twice as much in direct-to-physician marketing each year.  A candidate committed to these issues should address the rough reality that drug ads are just the tip of a really big iceberg: the potential for conflict of interest spills into academic medical centers, university research, continuing medical education, and physician marketing.  We must address those areas, too, if we are to truly tackle our nation’s prescription problem.