Momentum To Allow Medicare To Negotiate Lower Drug Prices Grows With Over 155 House Democrats Urging Action

70 Percent Of House Democrats Urge Biden To Include Medicare Negotiation In American Families Plan

WASHINGTON, D.C. — The following statement was issued by David Mitchell, a cancer patient and founder of Patients For Affordable Drugs Now, commenting on the letter from more than 155 House Democrats today calling on the White House to deliver on campaign promises to lower drug prices through Medicare negotiation as part of the American Families Plan:

“Today the message from Congress is clear: Allowing Medicare to negotiate lower drug prices must be a top priority this year. Over 155 members of Congress — 70 percent of the House Democratic Caucus — have now joined in calling on the president to make Medicare negotiation a part of the American Families Plan to bring relief to patients. Nine out of 10 Americans support Medicare negotiation, and momentum for its enactment is growing in Washington and across the country. We intend to help the president and supporters in Congress get it done this year.”

Background: 

• The letter — which is signed by 70 percent of the House Democratic Caucus, including moderates, progressives, and more than one dozen frontliners running in the most competitive districts across the country — calls on the White House to lower the price of prescription drugs by empowering Medicare to negotiate drug prices for all Americans, saving more than $450 billion over the next decade.
• The president promised to lower drug prices:
  • “Let’s give Medicare the power to save hundreds of billions of dollars by negotiating lower drug prescription prices,” President Biden said in his address to a joint session of Congress. “Let’s do it now.” 
  • The president re-affirmed his support for letting Medicare negotiate in his American Families Plan, which states, “President Biden has a plan to … lower prescription drug costs for everyone by letting Medicare negotiate prices.” 
• H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act, is a Medicare negotiation bill that was reintroduced in April and would:
  • Allow Medicare to negotiate for lower drug prices and extend lower prices to all Americans with public or private sector insurance.
  • Limit the negotiated price of drugs in Medicare to no more than 120 percent of the average of six other OECD nations.
  • Limit annual out-of-pocket costs for Medicare beneficiaries to no more than $2,000. 
  • End drug company price gouging by penalizing drug companies that increase prices in Medicare Parts B and D faster than the rate of inflation. 
  • Support innovation and new drug development by investing some of the expected savings into the world-class research supported by the National Institutes of Health.
• Patients support H.R. 3: 
  • Pro-reform forces, including AARP,  Patients For Affordable Drugs Now, and Protect Our Care, are mobilizing to meet the fury of Big Pharma opposition to Medicare negotiation head-on with thousands of letters and phone calls to members of Congress and millions of dollars in ads to support congressional allies.
• With Medicare negotiation, patients will pay less for their prescriptions and lives will be saved. 
  • Right now, more than 1.1 million Medicare patients could die over the next decade because they cannot afford to pay for their prescriptions. 
  • If Medicare were empowered to directly negotiate prices with drug companies, there could be 94,000 fewer deaths annually.
• Medicare negotiation is overwhelmingly popular — Americans want reform. 
  • Nine out of 10 Americans back Medicare negotiation, including 97 percent of Democrats, 87 percent of independents, and 84 percent of Republicans. 
  • Lowering the cost of prescription drugs and health care far outpolls even infrastructure investments as a priority for Americans.
  • Nearly 90 percent of small business owners say that drug costs are too high. Medicare negotiation would save employers $195 billion and employees $61 billion from 2023 to 2029.
  • Americans don’t buy Big Pharma’s main argument that lowering prices will stifle innovation, even when asked within the context of new vaccines.

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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. — In response to the House Ways and Means Committee unanimously passing H.R. 2113, legislation aimed at stopping drug price gouging and shedding light on secret PBM activity, Ben Wakana, the Executive Director of Patients For Affordable Drugs Now, issued the following statement:

“The bipartisan bill that passed today is a small step toward addressing an issue that 8 in 10 Americans say is a top priority. Patients appreciate Chairman Neal, Ranking Member Brady, and members on both sides of the aisle for working on an issue that is sending far too many Americans into debt.

“While we want to recognize today’s small win over Big Pharma, more action is necessary to help patients and lower prescription drug prices. We look forward to working with Congress to see further reforms enacted.”

BACKGROUND:

PRICE GOUGING: Language included in today’s bill would require drug manufacturers to provide written justification for price increases of 10 percent or $10,000 over 1 year, 25 percent or $25,000 over 3 years, or a starting drug price of more than $26,000. The drug company’s justification would be made public on the HHS website and failure to report justification would result in a $10,000 per day fine.

PBM TRANSPARENCY: Language included in today’s markup would make public on HHS’ website information on PBM rebates. The information would include, by drug class, the aggregate amount of rebates, discounts, or price concessions that are passed through to the plan sponsor.

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WASHINGTON, D.C. — In response to the House Energy and Commerce Committee passing the CREATES Act and legislation to end pay-for-delay tactics, David Mitchell, a cancer patient and the founder of Patients For Affordable Drugs Now, issued the following statement:

“Many Americans have lost faith in Congress’s ability to fix problems. Today, the Energy and Commerce Committee proved that small but important bipartisan reforms are still possible. I appreciate Chairman Pallone, Ranking Member Walden, and members on both sides of the aisle for working on one of the most critical issues facing Americans — skyrocketing prescription drug prices.

“Today’s actions must be the first step by this Congress on the path to lower drug prices, not the last. Even when these bills are signed into law, Americans will still go into debt at the hands of drug companies.

“More action is required to fix our broken system and lower prescription drug prices. We look forward to working with Congress to see further reforms enacted.”

BACKGROUND:

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 would address delay tactics that are used by brand drug manufacturers to block lower-priced generic drugs. The U.S. 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. HR 1449, the Protecting Consumer Access to Generic Drugs Act  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.

PATIENT PERSPECTIVE:

Celgene’s cancer medication, Revlimid, tops a list maintained by the FDA that highlights which brand pharmaceutical corporations are blocking generic competition. The maneuver puts patients like Pam Holt’s life and financial wellbeing at risk. The cancer patient took on $10,000 in debt and refinanced her home to afford Revlimid, telling Patients For Affordable Drugs:

“Celgene, the company that makes Revlimid, should be giving samples to generic drug makers so they can make a cheaper version, but it repeatedly refused to do so. Celgene is abusing a loophole in our laws to keep the price high. The company keeps raising the price simply because it can. And, I keep taking on debt.”

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WASHINGTON, D.C. — In response to a hearing today in the Energy and Commerce health subcommittee on a package of bills to lower drug prices, Ben Wakana, Executive Director of Patients For Affordable Drugs Now, issued the following statement:
 
“American patients are standing inside a burning house, and Congress needs to pick up the firehose. Today’s hearing was a step toward ending some of the most egregious practices by drug corporations, but the drug pricing crisis requires greater urgency and additional solutions from our nation’s leaders. Patients cannot wait any longer.”
 
BACKGROUND

• Nearly eight in 10 Americans (79 percent) say the cost of prescription drugs is “unreasonable.” The public sees profits made by pharmaceutical companies as the most significant factor contributing to the price of prescription drugs. At least eight in ten – across party identification – say profits made by pharmaceutical companies are a “major factor” in the price of prescription drugs. — (Kaiser Family Foundation)
• One in four adults (24 percent) say it is difficult to afford their prescription drugs. Nearly one in three adults (29 percent) report not taking their medicines as prescribed at some point in the past year because of the cost. One in five (19 percent of total) report that they haven’t filled a prescription or took an over-the counter drug instead (18 percent of total), and more than one in ten (12 percent) say they have cut pills in half or skipped a dose because of cost. — (Kaiser Family Foundation)
• More than eight in 10 Americans (86 percent) support allowing the federal government to negotiate with drug companies to get a lower price on medications for people with Medicare. This approach is favored by large majorities of Democrats (90 percent), independents (87 percent), and Republicans (80 percent). — (Kaiser Family Foundation)
• The CREATES Act would address delay tactics that are used by brand drug manufacturers to block lower-priced generic drugs. The U.S. could save $3.9 billion by stopping this abuse, which the FDA has called “unfair and exploitative.” — (Center for Biosimilars)
• According to an FTC study, anticompetitive pay-for-delay deals cost consumers and taxpayers $3.5 billion in higher drug costs every year. Since 2001, the FTC has filed a number of lawsuits to stop these deals, and it supports legislation to end such pay-for-delay settlements. — (FTC)

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WASHINGTON, D.C. — In response to comments President Trump made in his State of the Union Address about prescription drug prices, David Mitchell, a cancer patient and the founder of Patients For Affordable Drugs Now, issued the following statement:
 
“We appreciate President Trump’s continued focus on the country’s drug pricing crisis. But, two years into his term, prices are still going up, patients are still struggling, and Big Pharma is breaking records lobbying Congress to keep it that way.
 
“We’re glad the President touched on his plan to bring U.S drug prices more in line with what other wealthy countries pay. The International Pricing Index would lower the cost of America’s most expensive drugs by 30 percent. The plan has merit, and we urge the President to advance this proposal.
 
“That being said, not nearly enough has been accomplished and additional action is urgently needed. The list prices of drugs need to come down. Patients need Congress and the Executive branch to fix our broken system.
 
“Every day, Americans experience heartbreaking stress and financial pain due to high drug prices. Ruth Rinehart, of Tampa, Florida’s $52,000 prescription drug costs forced her to declare bankruptcy and lose her family home. The time for action is now.”
 
BACKGROUND
 
Drug costs are out of control

• Americans spend more than $450 billion each year on prescription drugs — by some estimates, nearly one-fifth of all health care costs go toward prescription drugs.
• The main driver of prescription drug spending is patent-protected brand-name drugs, which make up only about 10 percent of prescriptions but account for three-quarters of drug spending.

 
Americans pay more for drugs than any other country

• CNN: “Americans pay anywhere from two to six times more than the rest of the world for brand name prescription drugs.”
• The New York Times: “A government study said Medicare was paying 80 percent more than other advanced industrial countries for some of the most costly physician-administered medicines.”
• Senate Finance Congressional Testimony: “Revenues generated just from sales in America would fund 176 percent of the global pharmaceutical research and development budgets for these companies.”

 
Drug prices are rising, not falling

• Associated Press: An analysis found that through the end of last July there were 4,412 brand-name drug price increases and merely 46 price cuts—a ratio of 96-to-1.
• U.S. Department of Health and Human Services: Medicare beneficiaries’ costs for branded drugs rose by 40 percent — from $161 in 2011 to $225 in 2015.
• Health Affairs/Vox: “Prices for drugs of all types and from all classes (brand-name, specialty, generics/oral or injectable) have been rising faster than inflation…from 2008 to 2016.”

 
High drug prices hurt patients

• Kaiser Family Foundation: 1 out of 4 patients report that in the past year they or a family member have not filled a prescription (24 percent) or have skipped a dose or cut pills in half (19 percent) because of the cost.
• NPR: “Insulin’s high cost leads to lethal rationing.”
• Vox: “It means that our system, even if we don’t like to admit it, has to pick and choose who gets access to lifesaving drugs.”

 
Drug companies are rich and excessive

• The Washington Post: “9 out of 10 big pharmaceutical companies spend more on marketing than on research.”
• JAMA: “From 1997 through 2016…DTC prescription drug advertising increased from $1.3 billion to $6 billion with a shift toward advertising high-cost biologics and cancer immunotherapies.”
• Axios: “Nine drug companies are spending a combined $50 billion on new share buyback programs…The large buyback programs are rolling out while the same pharmaceutical companies raise drug prices and while Americans struggle to afford their prescriptions.”
   

Big Pharma rigged the system

• Open Secrets: “Pharmaceutical groups are spending heavily to influence public opinion and policy as rising drug prices become an increasingly mainstream political talking point. The industry claimed the top spot among lobbying spenders in 2018 — roughly $280 million — with no other industry coming close.”
• STAT News: “PhRMA spent a record-breaking $27.5 million on lobbying in 2018.”
• Axios: “Those totals don’t include the millions individual drug companies spent on their own lobbyists. They also don’t include the industry’s campaign contributions, which topped $17 million in the 2018 cycle.”

 
Americans demand reform

• Harvard/Politico: 8 in 10 Americans want Congress to act and lower prescription drug prices.
• Kaiser Family Foundation: “72 percent of people think the drug industry has too much influence in Washington — outweighing the 69 percent who feel that way about Wall Street or the 52 percent who think the NRA has too much power.”
• GS Strategies: There is overwhelming bipartisan support for the CREATES Act. More than 83 percent of voters support passage of the CREATES Act and almost 6 in 10 strongly support it.

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WASHINGTON, D.C. — After today’s Senate Finance Committee and House Committee on Oversight and Reform hearings on skyrocketing prescription drug prices, David Mitchell, a cancer patient and the founder of Patients For Affordable Drugs Now, issued the following statement:
 
“Today’s hearings are an encouraging start. It’s clear that there is bipartisan support to rein in Big Pharma’s monopoly pricing power.
 
“We are not surprised that drug corporations refused the Senate Committee’s invitation to participate. Those drug company CEOs can’t defend the indefensible.
 
“We look forward to helping Congress stand up to the drug industry and begin to actually lower drug prices for patients. Unchecked, drug company executives will continue to hold patients hostage to increase their profits. Congress needs to let them know that these abuses won’t stand any longer.”
 
BACKGROUND:

• Millions of Americans don’t take their medications because of high prescription prices.
• The government’s failure to negotiate on drug prices hurts patients and taxpayers. According to a recent study in JAMA, Medicare Part D could have saved $14.4 billion in 2016 alone by negotiating as the Department of Veterans Affairs does.
• A recent Harvard/Politico poll showed that 80 percent of American people say that Congress’ top priority should be action to lower drug prices. 

PATIENT PERSPECTIVE:

• Joan Tramontano, 77, of Venice, Florida spent a career in public relations, saving all she could for retirement. After doctors diagnosed her with GIST, or gastrointestinal stromal tumor, she was prescribed Gleevec in 2009, a Novartis drug that rose in price from $26,000 in 2001 to $140,000 in 2017, an increase of nearly 440 percent.
  
  “My out-of-pocket for that drug with Medicare Part D insurance has come, so far, to $60,000, cutting deeply into my retirement money, which is incredibly devastating and scary. I’m so glad to see Congress, with investigations and hearings, focusing this week on Novartis and a drug that has caused so much financial devastation and worry to me. Patients like me need Congress to act to lower drug prices soon.  We hope the future will bring legislation to finally negotiate drug prices, crack down on excessive price hikes, bring more transparency to our system, and protect patients from unfair price gouging.”

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WASHINGTON, D.C. — Patients For Affordable Drugs Now applauded and thanked the Senate Judiciary Committee for passing the bipartisan CREATES Act — a bill that aims to lower drug prices by speeding generics to market. In response to the committee voting 16 to 5 to move the bill for consideration by the full Senate, Executive Director Ben Wakana issued the following statement:

“Months of intense opposition from Big Pharma could not kill this bill, and nothing will stop patients from demanding solutions like the CREATES Act to lower drug prices. Chairman Grassley, Senator Leahy, and all committee members voting yes deserve credit for fighting for patients today. Drug corporations should stop safeguarding bad actors and instead focus on getting affordable medicine to Americans who need it.”

BACKGROUND:

• The CREATES Act (S. 974 and H.R. 2212) would stop big drug companies from blocking competition by refusing to allow their brand name drugs to be used in testing needed to get approval for generic competitors. If passed, patients would get access to lower-priced generic drugs faster.
   
• Eighty six organizations representing patients, doctors, the research and development community, and large employers sent letters urging Congress to pass the CREATES Act.
   
• The Congressional Budget Office estimated the CREATES Act would save taxpayers $3.8 billion over 10 years.
   
• In May, the FDA released a list of more than 50 drug makers accused by generic drug corporations of stalling providing samples that would increase competition and lower prices. According to Kaiser Health News, the drug makers on the FDA’s list are also responsible for double-digit percentage price hikes since 2012, which cost Medicare and Medicaid nearly $12 billion in 2016.
   
• The pharmaceutical lobby amped up lobbying to $25 million last year and continues to oppose the CREATES Act despite calls from Scott Gottlieb, conservative groups like FreedomWorks, and Harvard academics to end REMS abuses.

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