The Alliance

The Weekly Dose | 05.31.19

May 31, 2019 12:06 pm

The Alliance to Protect Medical Innovation has two central mandates: 1) push back on all the misinformation around drug prices, and 2) highlight many of the biopharmaceutical industry’s innovative new treatments and the impact of those discoveries on patients. We are proud to release our first original video that falls squarely in the second bucket. The piece, entitled “A Case for Innovation: Sickle Cell,” tells the story of an entrepreneur and single mother who suffers from sickle cell disease and a cutting-edge biotechnology company that is developing new treatments for this debilitating disease.


We spend a lot of time focused on the debate around drug prices. We produced this video as a chance to take a step back from that debate to remind people that this is an industry largely populated by people who want to make real and lasting change for patients, and of the hope those discoveries represent for patients who want to live a better life.


If you have questions, please email us. We look forward to working with you.



Patrick O’Connor – Executive Director

Rosemarie Calabro Tully – Communications Director




 #Drug “companies may create a drug that aims to treat one thing, only to find out during #ClinicalTrials that it’s effective at treating something else. But in those cases, they’re not closing themselves off to an unexpected result.” via @FastCompany: Click here to RT.

"Since 2000, @PhRMA companies have collectively invested half a trillion dollars in the search for new treatments and cures, including more than $70 billion in 2017, an amount twice the entire operating budget of the @NIH." - Lisa Joldersma #DrugPricing #Innovation Click here to RT.

With an avg of $2.8B in investment, 10-15 yrs to bring a new #drug to market, and a 90% failure rate, this kind of risk needs to be properly incentivized or investors will simply bring their capital elsewhere. #Patients waiting for a cure deserve continued #innovation. Click here to RT.



What Is Binding Arbitration? House Speaker Nancy Pelosi (D-Calif.) has endorsed the use of binding arbitration under Medicare. What is binding arbitration, what has the Speaker proposed and how will it affect innovation? We explore. Read the full blog post here.

In case you missed them, here are some other recent posts on the APMI blog:

- What Is A PBM?

- Truth Behind The Buzzwords

- The Worth Of A Thing Is What It Will Bring



Warning: Be Careful When Changing U.S. Patent System. House and Senate legislation would erode drug manufacturers’ intellectual property rights and innovation, argues the Institute for Policy Innovation’s Merrill Matthews in The Dallas Morning News. Most observers also misunderstand the patent system for new drugs, and improvements to existing drugs. As Matthews explains: “Currently, drug manufacturers receive 20 years of patent protection on new products. … That patent countdown clock starts as soon as a company files a patent application. At that stage of the research process, a medicine is better described as a hope than a product. … Only a fraction of potential medicines actually receive FDA approval.”

Hope For Patients With Cystic Fibrosis. As STAT News reports, “Vertex Pharmaceuticals has spent the last decade plus developing a mosaic of medicines for cystic fibrosis, targeting individual genetic nuances with the goal of eventually having something to offer everyone with CF. Right now, its drugs address about half of the patient population, but that number could rise to 90 percent next year.”

Canadian Drugs Aren’t Canadian … And Won’t Bring Down Prices. In S. News & World Report, Holly Strom and Kenneth Schell, past presidents of the California State Pharmacy Board, argue importing drugs from countries like Canada won’t address concerns about drug prices, and could harm patients. The two note, “In 2005, the Food and Drug Administration found that nearly half of the imported drugs intercepted from four developing countries were marketed as ‘Canadian.’ They found that the vast majority -- some 85 percent -- of ‘Canadian’ drugs actually came from 27 other countries. Last year, was fined $34 million by U.S. prosecutors for selling two cancer drugs with no active pharmaceutical ingredients.” The Heartland Institute also tackles the importation debate.

“Arbitration Is Just A Fig Leaf For Government Price Controls.” House Speaker Nancy Pelosi (D-Calif.) reportedly supports binding arbitration for Medicare. In the Orange County-Register, Frontiers of Freedom President George Landrith argues this policy would have the same effect as price controls. Landrith explained, “If binding arbitration takes off, Americans may never benefit from these potential treatments. Instead, patients would be left at the mercy of diseases for which there are currently no cures.” Center for Innovation and Free Enterprise President Dee Stewart also takes on the arbitration idea in Morning Consult, as does Frontiers for Freedom Senior Fellow Peter Roff in the Houston Chronicle.

Putting Prices In Drug Ads Won’t Address Costs. Speaking to Healthline, Dr. Sara Ellison, an economist at MIT, explained putting drug prices in ads is “not likely to have a big effect” because the pharmaceutical market is different from other consumer product markets, like electronics or home appliances, for example. The article says, “If two people go to a store to buy a laptop or a refrigerator, they will usually pay a similar price. One person may find a better deal, but it’s not drastically lower. With prescription drugs, what you pay out of pocket depends on many factors — whether you have health insurance, what your copayments and deductibles are, whether the drug is included on your plan’s formulary, and if there’s a pharmacy benefit manager (PBM) involved.”

Lack Of Competition: A Few PBMs Control The Market. According to Axios, “CVS Health, Express Scripts (now owned by Cigna) and OptumRx (owned by UnitedHealth Group) continue to control a vast majority of the drug insurance market, according to new estimates from Adam Fein of the Drug Channels Institute. The bottom line: Those 3 pharmacy benefit managers handled more than 75 percent of all prescription claims in 2018. The big picture: Employers usually don't switch drug benefits companies because they don't want to enrage their workers with the changes, which has given the big 3 players longstanding power in the market.”

More Cancer Treatments Are In Development. STAT News reports that the world is spending more on cancer treatments … because there are more treatments available. According to IQVIA, 2018 saw 15 new cancer drugs marketed around the world, and the pipeline of treatments in late-stage development grew by 19 percent over 2017.



In a Forbes column, Pacific Research Institute Senior Fellow Wayne Winegarden explains how proposed changes to the U.S. patent system would erode drug innovation: 

“On average, it costs around $2.6 billion and 10 to 15 years to develop one new medicine. While not all drugs make it to the clinical trial stage, of those that do, only 12 percent will be approved for marketing. This expensive research and development process does not stop simply because the medicine has been approved for marketing. Just like most other industries, whether it is the iPhone or a Ford F-Series truck, the developers of a new biologic medicine do not stop investing in their products simply because the medicine has been approved and is being sold on the market. In the case of new biologic medicines, these new investments are dedicated toward improving the efficacy or diminishing the adverse side effects of the medicines. … Often, these investments result in new intellectual property that, in order to allow the investing companies an opportunity to recoup their costs, should be patented. The justification for these additional patents is no different than the justification for the original patent.”



Thursday, June 20, 2 p.m.: Information Technology and Innovation Foundation

Location: Russell Senate Office Building, Room 385

Topic: The Cost of Cures: Drug Price Controls vs. Biopharmaceutical Innovation

Agenda: There is an increasingly intense focus in Washington on reducing the price of drugs to bring down health-care costs. President Trump has proposed a plan that would use an international pricing index model for drugs under Medicare Part B. There are proposals from both sides of the aisle in Congress as well including various forms of government-led arbitration and changes to U.S. patent laws. But much of this debate is taking place without systematic consideration of what effect, if any, mandated drug-price reductions would have on biopharmaceutical innovation and U.S. industry competitiveness.