As patients and consumers, we face more and more choices about our health care each year.

We all support consumer empowerment in decisions about their care, but consumers don’t always have all the information they need to choose between different prescription drugs.

And the billions of dollars that the drug industry spends on advertising to patients and doctors is designed to make things worse. Industry advertises expensive new drugs, but not equally effective and lower-cost alternatives.

But trends are changing. State laws promoting the use of generic medications have saved consumers hundreds of billions of dollars. Employers are educating their employees to emphasize value — getting an equally effective drug that costs one-tenth as much as a brand-name option. For example, skipping the $200-a-month Nexium, and choosing Prilosec — made by the same manufacturer with the same active ingredient — for just $27.

Whether you or your organization’s members are uninsured, have high copays, or just want to be sure to get the best value for their health care dollar, these resources can help advocates, doctors, and patients make better choices for their health – and their wallets.

The Truth About Generics – safe and affordable

Generics are as safe and effective as their brand-name counterparts, but can cost 90 percent less. Go here to see why generic drugs are an affordable option used by nearly all patients.

New Generic Drugs Coming this year, and next!

Is your drug going generic soon? Dozens of expensive brand-name drugs like Cipro and Provigil have become generic, and their prices are dropping… Generic Plavix costs less than $15 even without insurance. See this year and next year’s newest generic drugs.

Uninsured? Here are some ultra-low cost options

Go here to see why, and see how you can find hundreds of drugs for $4 or $5 — many of the same drugs that you may be taking now, available at a lower cost. And learn why drug costs can vary so much from pharmacy to pharmacy.

If an expensive brand name drug is your only option, and you meet other insurance and income qualifications, a local hospital or community health center may be able to help you find low cost medicines. Find out more here.

Is that drug coupon a good thing? Maybe not!

Did you find a coupon by a drug manufacturer online? You should think twice about using it to make Nexium or some other drug more affordable. Read this to see how these coupons can actually turn over your personal private health information to the drug company, and cost you more in the long run. If you have drug coverage through Medicare or Medicaid, using a manufacturer coupon is prohibited by federal law.

Please help us share these resources!

These consumer resources were created through the generous support of the California HealthCare Foundation, and are intended to be shared freely with the public, including on other organization’s websites.

Please contact us at wwilkinson(at)communitycatalyst.org if we can help you share these resources with your members, assist you posting them on your website, or if you want to host a guest blog on ways to find affordable medications.

– Wells Wilkinson,  Project Director
Prescription Access Litigation

We are shocked and distressed to learn of the 24 deaths and 328 illnesses caused by the meningitis-contaminated painkiller injections produced in a Massachusetts compounding pharmacy, the New England Compounding Center (NECC). Our thoughts are with the families of those patients and the 14,000 more who are waiting to learn if they were infected by their medical treatment. While the news continues to develop, we are still waiting to fully understand what went wrong, what the company should have done to prevent this, and what are the state and federal agencies with oversight responsibilities.

This tragedy reinforces our commitment to ensuring that all people have a right to trust the safety and purity of the medicines they take. As we have learned from advocating for the major drug manufacturing safety legislation passed this year by Congress, the pharmaceutical supply chain is extremely complicated. Now everyone is recognizing that compounding pharmacies are an important, additional link in that chain.

Weaknesses in the global supply chain became painfully apparent in 2007-2008 through another tragedy, when dozens of U.S. patients suffered adverse effects and some died after receiving heparin, a blood-thinner used in dialysis treatments that had been contaminated during its manufacturing in China. Many things contributed to that failure in the supply chain, including the increasingly globalized nature of pharmaceutical manufacturing and insufficient FDA resources and authority to manage it. For example, 80 percent of Active Pharmaceutical Ingredients used in drugs sold in the U.S. are produced overseas. And for a long time, the FDA has not had the resources to inspect all of these suppliers and finished manufacturing operations. Domestic plants were being inspected approximately once every two years, but foreign plants averaged once every nine years, and some were never inspected.

Fortunately, this summer, with broad support from advocates and many in industry, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA) to address the problems that contributed to the heparin situation. FDASIA requires companies to implement robust “Good Manufacturing Processes,” other controls and transparency throughout the supply chain, from the raw materials to the finished products. It requires manufacturer and importer registration and risk-based inspections in both domestic and foreign plants, which should increase the frequency in foreign plants. There are new user fees for generic companies to support increased inspections, with a goal of parity between U.S. and foreign inspection rates. And there is much stronger enforcement and higher fines. While FDASIA has some weaknesses—FDA still does not have mandatory recall authority, a minimum schedule of inspections at all plants or protections for whistleblowers—the law is a huge step forward in ensuring safety of the drugs produced by registered manufacturers.

But compounding pharmacies like NECC appear to fall outside of FDASIA. They are licensed only to prepare specialized or modified drugs for individual patients with an individual prescription. Massachusetts has now ruled that NECC violated its license by selling in bulk, by acting as a typical manufacturer. For years NECC has carried out sophisticated marketing operations throughout the country, leading to big production increases and to the unfolding tragedy today. Yet compounding pharmacies have lobbied for a decade to avoid stronger regulation and as a result even more patients were potentially affected by their practices.

Ironically, compounding pharmacies have been helping to fill the gaps when drug shortages occur—and many of these shortages are a result of problems at domestic and overseas conventional drug manufacturers that have had to temporarily close plants or production lines. This is another sign FDASIA was long overdue, since company quality control systems and FDA regulation have not kept pace with the brave new world of globalized drug manufacturing. Small scale compounding pharmacies can legitimately help fill such gaps for the benefit of individual patients, although they too should be required to have strong quality assurance systems in place.

At this time there are many efforts being undertaken by state and federal lawmakers and regulators to identify precisely what legal authority currently exists for regulating compounding pharmacies and what additional oversight and resources are needed to ensure the safety of compounded drugs. We support the efforts of Congress, the FDA, state boards of pharmacy, pharmacy retailers, drug manufacturers, and other patient advocates in finding solutions to ensure the supply chain is strong and that Americans can again trust the medicine they rely on.

 – Anna Dunbar-Hester, Policy Analyst &
Marcia Hams, Prescription Access and Quality Program Director

Community Catalyst and 18 other consumer, patient safety and labor groups weighed in last week in support of (with important “friendly amendments”) draft regulations issued by the Centers for Medicare and Medicaid Services (CMS) requiring that the drug, biologics and medical device industries publicly report all payments to physicians and teaching hospitals. See here and here. As a result, all of these industry payments will be displayed on a publicly available website, where the information can be viewed by patients, or downloaded and studied.

Over 300 organizations submitted comments on these “sunshine” provisions of the health reform law. That’s a surprising number of comments, given that the provision doesn’t affect a patient’s right to benefits, or set up a new program or regulate insurance. The provision simply requires transparency in virtually all drug and device industry payments to physicians and to the teaching hospitals that train doctors or host biomedical research. Such transparency is critical for patients and the health care system, because it can expose industry marketing that undermines good prescribing, trust in doctors and affordable care. As Senator Chuck Grassley, who long championed the bill with Senator Herb Kohl, said 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.”

This transparency program was slated to go into effect on January 1 of this year, but the Department of Health and Human Services and CMS have been behind on issuing the rules. All 18 consumer and labor groups urged that this transparency be started as soon as possible after the final rule is issued. There’s no legitimate reason to delay further, because the nation’s biggest drug makers have already been reporting their payments as a result of federal investigations or settlements of possible illegal kick-backs paid to doctors. And nearly all of these manufacturers have been reporting these payments to the States of Vermont, Minnesota and Massachusetts, under state transparency laws.

The proposed rules address many complicated issues. For instance, how any payment to a doctor is labeled, as a ‘gift’ or ‘consulting fee’ or a payment for ‘research,’ etc. We urged CMS to adopt clear-cut, non-overlapping definitions to ensure that all the information is accurate, understandable to the public, and not open to manipulation. We also applauded a number of CMS proposals to improve the public’s ability to understand what payments are for, such as separating ‘lump sum’ payments into smaller units. This will help prevent industry from trying to bury inappropriate payments for lavish meals or travel to fancy resorts within a larger payment for ‘education’ or ‘research.’

We also applauded CMS efforts to prevent loopholes, by including all drug and device manufacturers, regardless of whether their products are manufactured overseas, and by including payments made to doctors through third parties, where appropriate. Plugging these potential large loopholes is essential to real transparency.

Under the statute, research payments must be reported but can be delayed for four years to protect industry from competition during product development. However, we urged CMS to narrow the definitions so that payments related to research on new uses (such as ‘off-label’ uses) of drugs, biologicals and invasive implanted devises are not delayed. Numerous federal investigations and prosecutions have exposed the illegal promotion of unapproved, or ‘off-label,’ uses of drugs and devices, fostered in part by inappropriate industry ties to physicians. This has resulted in widespread harm to consumers. For instance, the illegal ‘off-label’ promotion of the epilepsy drug Neurontin resulted in 90 percent of its prescriptions being for unapproved uses. Promotion of unproven medical devices is also increasingly a problem. As a result, we asked CMS to require that payments related to ‘research’ on products that are actively being prescribed not be subject to any delay.

Finally, CMS proposed to require CEOs to personally attest to the accuracy of their company reports. We heartily agree with this requirement—accountability should be the bottom line for any company that produces the drugs that patients ingest or the devices implanted in a patient’s body.

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

For more see this post.

(from today’s Health Policy Hub)

A negative court decision this week underscores the importance of passing federal legislation to ban ‘pay-for-delay’ settlements in order to preserve access to affordable, quality prescription drug benefits. At issue is the drug industry practice of paying off generic competitors of expensive brand-name drugs to delay access to low-cost generics.

On Tuesday, the Second Circuit issued a decision on the legality of pay-for-delay settlements concerning the drug Cipro that dealt a blow to consumer advocates and consumer protection attorneys challenging these collusive agreements in court. The decision rebuffed the Federal Trade Commission, the Department of Justice, and a group of State Attorneys-General, all of whom asked the Court to re-evaluate an earlier precedent from 2005 that allowed such ‘pay-for-delay’ settlements. For more background on the legal aspects of this issue, read this earlier blog by our Prescription Access Litigation project.

While the attorneys ponder whether to appeal the case to the Supreme Court, the importance of a legislative solution to this problem becomes even clearer.

Current legislation before the U.S. Senate proposed by Senators Herb Kohl (D-WI) and Richard Durbin (D-IL) would create a presumption that any drug patent settlement that exchanges a payment in return for an agreement to delay bringing a generic to the market is a violation of anti-trust law. The bill gives the FTC the tools to challenge such settlements. However, it still allows the drug companies to prove that a settlement is not a collusive agreement, but a legitimate effort to avoid the time and costs of litigation…

If a robust, competitive market is to play a role in our new health care system, shielding nearly 10 percent of all annual brand-name drug sales from market competition will only allow drug company price increases to continue depleting more and more of our health care resources, while putting more patient care at risk.

Read the full post by Prescription Access Litigation’s Wells Wilkinson here.