The Alliance

The Weekly Dose | 05.10.19

May 13, 2019 1:19 pm

The U.S. Senate Judiciary Committee discussed drug prices and the patent process this week. This issue is highly complex. A single hearing – much less the buzzwords relied on by drug company critics – is not sufficient to explain it. As a result, there was a lot of confusion this past week, and several misstatements, particularly about so-called “secondary innovation.”


Here is the truth: When a new patent is awarded, it’s applied only to that specific improvement, not the original product. These new patents don’t extend the original patent. As a result, generics drug companies can still sell the original version of the drug.


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Patrick O’Connor – Executive Director

Rosemarie Calabro Tully – Communications Director




I'm also concerned that we not take rash actions that cause harm outside of the pharmaceutical industry where #patents are critical. ... We have to make sure we are being careful about how we reduce costs without putting at risk the next generation of #innovation - @ChrisCoons Click here to RT.

Most Americans would be surprised to learn that overall spending on #prescriptiondrugs grew by less than 1% in 2017. Once rebates and other discounts were accounted for, #patients spent 2.2% less per-capita on their medicine. Want to learn more? Read here: Click here to RT.

What most headlines won't tell you is that 73% of Americans reported that it is easy for them to afford their #PrescriptionDrugs. Read more about @IAmBiotech's recent poll and what else it reveals about #DrugPricing: Click here to RT.



Incremental Or Secondary – It’s Incredibly Valuable. The Senate Judiciary Committee met this week to discuss the U.S. patent system and its impact on drug pricing. Listeners again heard several buzzwords – like “secondary innovation” and “evergreening” – as a handful of panelists and lawmakers outlined far-reaching suggestions for legislative changes. We explain how the proposals could reduce innovation. Read the full blog post here.

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

 - Truth Behind The Buzzwords

 - An Update On Drug Innovation In America

 - Addressing Common Myths About Private Sector R&D



How Much Do Drugs Cost Americans Out Of Pocket? Kaiser Health News has the answer: “With all the focus on affordability, it’s worth noting that about a third of all retail prescriptions come at no cost to the patient. Another half have an out-of-pocket cost of under $10. In recent years, the average out-of-pocket cost has fallen from about $10 to a bit over $8.”

Fact: The United States Drives Almost 60 Percent Of All Drug R&D. The nonpartisan nonprofit Citizens Against Government Waste notes the Association of the British Pharmaceutical Industry found that “in 2016, the U.S. led in total pharmaceutical R&D expenditures with 58 percent. Japan came in next at 13 percent, followed by the U.K. at 7 percent. Canada was at a measly 1 percent.”

Competition Works (And Brought About A Cure For Hepatitis C). The cost of treatments for Hepatitis C sparked controversy a few years ago. Now Axios says those “medicines are playing second fiddle to a competitor, and the drug that started it all, Sovaldi, has been relegated to a footnote. … The big picture: Gilead’s drugs were a major reason why pharmaceutical spending shot up in 2014 and 2015, as patients flocked to the high-priced pills that cure the disease for a vast majority of people. Sales have gone down considerably, due to competing drugs and restrictive insurance coverage, even though a large number of hepatitis C patients remain untreated.”

Oncologist: PBMs Denying Care To Cancer Patients. At STAT News, Dr. Jeff Vacirca, CEO of New York Cancer and Blood Specialists, tells heartbreaking stories of how pharmacy benefit managers (PBMs) came in between doctors and their patients, including this one: “An oncologist in Florida determined that her patient with metastatic kidney cancer needed to start taking a standard, first-line oral medication. But the patient’s pharmacy benefit manager decided it knew better and refused to authorize the medication unless a surgeon first performed surgery to remove a tumor on the patient’s kidney — despite the fact that the patient’s surgeon had already determined that the procedure was too risky and the patient wasn’t a candidate for surgery, something the surgeon had previously told the PBM.”

Progress On Breast Cancer Drug. Reuters reported this week that “an experimental breast cancer drug being developed by British drugmaker AstraZeneca and Japan’s Daiichi Sankyo’s met its main goal in a mid-stage study, bolstering their position in a highly competitive oncology market. … The treatment, also known as DS-8201, demonstrated a clinically meaningful response in patients who have metastatic breast cancer and a type of protein on the surface of cancer cells.”

Hope For Children With Rare Autoimmune Disease. Reuters also reported, “Jacobus Pharmaceutical Co Inc on Monday won U.S. approval for the first drug to treat children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder. The drug, Ruzurgi, was approved for use in patients aged between 6 and 17. … Lambert-Eaton myasthenic syndrome, which affects about three people per million worldwide, affects the connection between nerves and muscles, disrupting the ability of nerve cells to send signals to muscle cells. The treatment currently available has been approved only for adults.”

And One More: Hope For Children With Epilepsy. In one more report, Reuters reported “GW Pharmaceuticals Plc said on Monday its drug Epidiolex was successful in treating seizures in patients with a rare form of childhood epilepsy called tuberous sclerosis complex during a late-stage trial.”



The Washington Post’s Megan McArdle explains the consequences of capping drug prices:

“There’s a reasonable argument, of course, that Americans should be willing to forsake pharmaceutical research to make current drugs more affordable. But before going that route, everyone needs to be clear on what sort of decision is being made. Otherwise, it’s all too likely that cutting drug prices now, in the name of easing people’s budgets, will mean later discovering that we inadvertently sacrificed the lifesaving investments of the future.”


In a column in The Hill, Rep. Mark Meadows (R-N.C.) explains that American innovators bear the cost burden for the world because other nations set their prices artificially low:

“More new medicines are developed on American soil than anywhere else in the world. In fact, 118 of the 252 new medicines approved between 1998 and 2007 were developed in the United States. For context, the countries coming in just behind the U.S. only developed around 20 new medicines during that same period. But unfortunately, we have the highest prescription drug prices in the world because the below-market prices mandated by other governments mean that the U.S. shoulders the global burden for innovation. … Here’s the problem: Americans scientists and companies put in immense amounts of time, brainpower and money into researching and developing potential new medicines. When a new treatment is approved, it’s sold in other countries for less than the price paid by American patients. That’s because countries with government-run health care systems set prices at exceedingly low rates, getting a free ride at the expense of capitalism and more importantly, our own citizens.”



Thursday, May 16, 10 a.m. ET: U.S. House Committee on Oversight and Reform, Subcommittee on Civil Rights and Civil Liberties

Location: 2154 Rayburn House Office Building

Topic: HIV Prevention Drug: Billions in Corporate Profits after Millions in Taxpayer Investments

Agenda: Unknown

Contact: 202-225-5051