Latest News | May 6, 2019

Cancer Patient to Testify at Senate Judiciary Hearing on Rising Drug Prices

WASHINGTON, D.C. — On Tuesday, May 7 at 10:00 AM, Patients For Affordable Drugs Founder David Mitchell will testify before the Senate Judiciary Committee during a hearing on rising prescription drug prices.

Mitchell will discuss his journey as a patient with incurable blood cancer and will offer a number of solutions to lower drug prices. He will encourage bipartisan action to address this issue, including reforming the country’s patent laws, ending the days of monopoly pricing power without taxpayer negotiations, and forcing transparency from drug middlemen.

WHAT: Full Senate Judiciary Committee Hearing, “Intellectual Property and the Price of Prescription Drugs: Balancing Innovation and Competition
WHEN: Tuesday, May 7 at 10:00 AM
WHERE: Dirksen Senate Office Building 226, or watch online
WITNESSES: 
Joshua D. Barker, Director of the South Carolina Department of Health and Human Services
David Mitchell, President and Founder of Patients For Affordable Drugs
James Stansel, Executive Vice President and General Counsel of the Pharmaceutical Research and Manufacturers of America
Michael Carrier, Professor of law at Rutgers Law School
David S. Olson, Associate Professor at Boston College Law School

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WASHINGTON, D.C. — In response to the House Judiciary Committee passing a legislative package that would stop REMS abuses, curb anti-competitive pay-for-delay deals, address sham citizen petitions, and regulate PBM spread pricing, David Mitchell, a cancer patient and the founder of Patients For Affordable Drugs Now, issued the following statement:

“We are encouraged by continued Congressional action to address an array of abusive tactics Big Pharma uses to block competition and keep drug prices high. I am grateful to Chairman Nadler, Ranking Member Collins, and members on both sides of the aisle for their work on one of the most critical issues facing Americans — skyrocketing prescription drug prices.

“We still have a long way to go to fix our broken system and lower drug prices for all Americans. Today’s actions are a step forward, but certainly not the last. We are eager to work with Congress to continue down this path of reform.”

BACKGROUND:

Today’s hearing is the latest in a flurry of action on Capitol Hill to address what 8 in 10 Americans say is the “unreasonable” cost of prescription drugs. This year, the Senate Finance Committee, Senate Aging Committee, House Committee on Oversight and Reform, House Ways and Means Committee, and the House Energy and Commerce Committee have all held hearings or markups on the topic of skyrocketing drug prices. The latter two committees have both passed a bipartisan package of bills aimed at addressing Pharma abuses.

The topics included in today’s bipartisan-passed legislative package address: 

REMS ABUSES: Brand drug companies use a safety program called Risk Evaluation and Mitigation Strategies (REMS) as a pretext for not selling drug samples to generic companies, which need the brand product in order to develop an equivalent and lower-priced competitor. The CREATES Act — part of today’s legislative package — would address delay tactics that are used by brand drug manufacturers to block lower-priced generic drugs. Taxpayers could save $3.9 billion by stopping this abuse, which the FDA has called “unfair and exploitative.”

PAY-FOR-DELAY: Brand drug companies pay off generic companies that plan to bring a competitor to market. In exchange for this payment, the generic manufacturer delays its product’s entry into the market and the companies share in the fruits of the extended monopoly. The Preserve Access to Affordable Generics and Biosimilars Act, passed by the Judiciary Committee today, would limit deals in which brand and generic drug manufacturers use anti-competitive pay-off agreements to delay cheaper generic and biosimilar drugs from reaching patients.

SHAM CITIZEN PETITIONS: Citizen petitions can be filed at the Food and Drug Administration requesting FDA action. But brand name drug makers filed 92 percent of all citizen petitions between 2011 and 2015 — all aimed at blocking cheaper generic drugs. The FDA denied more than 9 of every 10 of those petitions. Today, the Judiciary Committee took a step toward ending that abuse by passing the Stop STALLING Act.

PBM SPREAD PRICING: Pharmacy Benefit Managers, the drug pricing middlemen, rip off taxpayers and patients with a practice called spread pricing, in which PBMs retain the difference between what they bill insurers and employers and what they pay to pharmacies. States like West Virginia, Ohio, Arkansas, Connecticut, and Kentucky have already investigated or cracked down on spread pricing in state Medicaid programs. The Prescription Pricing for the People Act of 2019, passed by the Judiciary Committee today, would authorize the FTC to study reimbursement practices of PBMs and issue a report with policy recommendations.

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WASHINGTON, D.C.  — Today’s congressional briefing featured a bipartisan panel of experts who agreed that International Reference Pricing can lower drug prices in the U.S. while maintaining innovation.

The speakers refuted drug companies’ unfounded claim that reference pricing will harm access or the development of new drugs. And the speakers explained how reference pricing is not price setting any more than the current system of ASP + 6 is price setting. Right now, Medicare sets prices based on a domestic reference price.

John O’Brien, Senior Advisor to the Secretary at the U.S. Department of Health and Human Services, noted that under HHS’ International Pricing Index, Medicare would receive a share of the discounts that drug companies voluntarily give to other countries, saving patients and Medicare $17 billion over the next five years while protecting innovation and access to medicine.

Rena Conti, Associate Professor at Boston University, argued that an International Pricing Index will lower drug prices, increase quality of treatment, and realign incentives for innovation that will lead to the breakthrough drugs we want.

Peter Bach, Director at the Center for Health Policy and Outcomes at Memorial Sloan-Kettering Cancer Center, focused on the fact that current incentives in Medicare Part B reward doctors for choosing higher-priced prescription drugs. He noted that innovative and effective drugs garner high prices in other countries. But drugs with competition or of limited value have lower prices. International reference pricing will reflect those market dynamics for this country.

Avik Roy, President of the Foundation for Research on Equal Opportunity, noted that there is no free market for drugs under Part B now. He explained how Medicare is required by law to pay for nearly all FDA-approved physician-administered drugs, regardless of a drug’s quality, price, or value. The IPIM as proposed by HHS would keep the coverage requirement in the US but peg prices to other nations that consider value and price.

David Mitchell, cancer patient and founder of Patients For Affordable Drugs Now,mentioned that there is no evidence the proposed HHS Part B demonstration or any current Congressional bills that utilize reference pricing would harm patient access to drugs, or hurt innovation.

BACKGROUND: How Reference Pricing Works

Right now, American taxpayers pay twice as much for prescription drugs as citizens in other wealthy nations. An International Pricing Index could bring American prices more in line with what other wealthy nations pay.

A Department of Health and Human Services Advanced Notice of Proposed Rulemaking as well as separate bills introduced by Senators Bernie Sanders, Jeff Merkley, Rick Scott, and Josh Hawley use International Reference Pricing as a tool to lower drug prices in the US while maintaining innovation and access.

Under an international reference price, Medicare would pay no more than a set percentage of the price other wealthy countries pay for certain prescription drugs.

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We hope you all have a chance to see Endgame this weekend. Our Endgame? Lower drug prices.

Welcome to the week in review in prescription drug pricing!
 
1. Fake patient advocacy on the rise

2. Woman v. The Machine

3. The Everglades

4. Good luck with that

5. America, meet the drug pricing vernacular

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Welcome to the week in drug pricing news — no redactions.
 

1. Big Pharma: “We are going to put prices on our websites*”

2. The Big Pharma tax windfall goes to…


3. Main-ahs look into wicked high prices


4. Constituent: “Hi, I’m not calling about the Mueller report.”


5.  Let’s make a deal.

WASHINGTON, D.C. — From coast to coast, patients are speaking out, and Big Pharma is on the run. Over the last two weeks, from California to Maine, states have taken meaningful steps to protect patients from higher drug prices and crack down on Big Pharma’s price gouging. Take a look:
 
Oregon (HB 2658)

Maine (LD 1162LD1272LD 1387LD1499)

California (AB 824)

Maryland (HB 768)

Massachusetts (HB 1133SB 706)

“Momentum is building across the country,” said Ben Wakana, Executive Director of Patients For Affordable Drugs Now. “Patients are turning up at statehouses to tell lawmakers just how harmful high drug prices have become — their voices are seeding a movement.”

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AUGUSTA, Maine — Maine patients will urge legislators to hold drug corporations accountable for exorbitant price hikes and give the state power to negotiate lower prices during hearings today and Wednesday before the Health Coverage, Insurance and Financial Services Committee. Patients For Affordable Drugs Now, a Washington, D.C.-based bipartisan patient advocacy organization that takes no money from the pharmaceutical industry, is helping patients share their drug pricing stories in Maine, sending four patients to testify at this week’s hearings on a package of bills to lower prescription drug prices. Patients For Affordable Drugs Now also published a series of patient stories on its website to underscore the urgency of the drug pricing crisis in Maine.
 
“Drug corporations have a direct line into Maine’s state coffers and patients’ pockets, and it’s time for the legislature to act,” said Ben Wakana, Executive Director of Patients For Affordable Drugs Now. “We’ve heard from nearly 250 Mainers who are suffering under relentless prescription drug price hikes. We applaud consumer groups and the state legislature’s efforts to rein in drug prices, and we are proud patients are standing up against abusive pricing practices.”
 
Here’s how the pending legislation would benefit Mainers:

Testifying at the hearings today and Wednesday are:
 
Lori Dumont of Brewer: “My brother suffered ketoacidosis because he could not afford his insulin. Like so many others, his insulin costs were out of control. For both his long term and short term insulin he was paying about $1,500 a month. On a fixed income, high drug prices are literally a matter of life and death.”
 
Sabrina Burbeck of Old Town: “When my youngest son was 18 months old he was diagnosed with Type 1 diabetes. In order to survive, he relies on Humalog Insulin. One vial of Humalog costs $350.”
 
Glenda Smith of Kennebunk: “My Symbicort, Lostatin, Spiriva, and other medications cost me more than $1,200/month, not to mention the $5,000 we have to pay out of pocket before insurance even begins to pay its portion. That is not realistic on our fixed income. My drug costs alone are more than my entire Social Security check.”
 
Christina Raymond of Limestone: “In order to manage my disease, I require several medications –– Lupron, Tamoxifen, and Neulasta –– in addition to my regular chemo treatments. Lupron costs me $1,500 per month and my Neulasta runs $6,000 per shot.”

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We finally know what a black hole looks like. Next black hole to face the cameras: justification for drug company price hikes.
 
1. Patients win

2. Counts for nothing

 
3. Do you like apples?


4. What a week in Washington

 
5. Walmart-ism