SACRAMENTO — A California grandmother plans to stand up to Big Pharma at a state senate hearing Wednesday, sharing her story about unaffordable prescription drugs and speaking in favor of AB 824 — a first-in-nation bill that would end a drug company tactic used to block lower-priced generic competition.
Karen Macedon, a Sacramento waitress who lives with asthma and type 2 diabetes, will tell the Senate Health Committee, “Not a day goes by when I don’t think about the impact these conditions have on my life and the growing burden of paying for the medications that treat them.”
Karen’s diabetes medication costs more than $800 a month. There is no generic option.
AB 824, legislation introduced by Assemblymember Jim Wood (D-Santa Rosa) and sponsored by state Attorney General Xavier Becerra, would make illegal a Big Pharma scheme called “pay-for-delay,” in which a brand drug maker pays a generic manufacturer not to bring a competitive product to market, driving big drug company profits and hurting patients waiting for less-expensive prescription drugs.
Macedon’s testimony will be delivered on Wednesday, July 3 before the Senate Health Committee at 1:30 PM.
Key points from Karen Macedon’s prepared remarks:
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HARRISBURG, Pa. — As Pennsylvania state lawmakers weigh key measures to protect residents from Big Pharma’s skyrocketing drug prices, patients are calling for reform. One bill would require more transparency from drug manufacturers, triggered by price increases that hit certain thresholds. A second measure would establish a Prescription Drug Pricing Task Force to study the issue of rising drug prices and recommend legislative solutions.
HB 568 would:
HB 1042 would:
“Pennsylvanians are desperate for relief from crushing drug prices,” said David Mitchell, a cancer patient and the founder of Patients For Affordable Drugs Now. “While there is still work to be done to lower the list prices of drugs, these important bills could give state residents more information about rising costs and reasonable solutions to assuage unrelenting price increases.”
Today, Patients For Affordable Drugs Now published a series of patient stories on its website to underscore the urgency of the drug pricing crisis in Pennsylvania.
Melissa Evans, Wilkes-Barre, PA: “Affording all of the medications I need to survive has become such a burden. I have to make many difficult decisions to make sure my needs are met. Half of the time I don’t even take my prescriptions because the co-pays are just far too high. I don’t fill it if I can’t afford it –– it’s as simple as that.”
Michelle Rzeplinski, McAdoo, PA: “These drug prices are killing me, both in the physical and the financial sense. If my drugs were more affordable, my health would greatly improve. Lower prices would mean better access to the medications that are prescribed to me.”
Lynn Seabrook, Wilkes-Barre, PA: “It is sad to say, but I sometimes feel like I would be better off dead –– especially at the end of the month, after prescriptions have been purchased and we are completely broke. My husband has not had a new pair of shoes in years, and I worry about the burden my drug costs places on my family.”
BACKGROUND:
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WASHINGTON, D.C. — In light of today’s news that Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT) introduced a groundbreaking bipartisan bill that would outlaw two tactics Big Pharma wields to maintain monopoly pricing power, David Mitchell, a cancer patient and the founder of Patients For Affordable Drugs Now, issued the following statement:
“Drug corporations have run amok — abusing our patent system and leaving Americans bankrupt and sick. Two egregious tactics they use to maintain high prices are patent thickets and product hopping. Drug companies file scores of patents in an effort to thwart generic competition, or they bring a new drug to market with small, inconsequential differences in order to prevent a competitor from entering at a lower price. These tactics block free-market competition and keep drug prices high.
“We wholeheartedly endorse the Affordable Prescriptions for Patients Act, and we applaud the work of Senators Cornyn and Blumenthal. This bill will speed generic drugs to market without hurting innovation.
“Momentum is building as Republicans and Democrats collaborate to fix our broken system. We look forward to working in support of this legislation, and we hope today’s bill will be included in any upcoming package of reforms.”
BACKGROUND:
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WASHINGTON, D.C. — Patients For Affordable Drugs founder David Mitchell will tell his story of living with incurable blood cancer and will debunk Big Pharma’s claim that patients won’t get innovative drugs without paying high prices at a 10:00 AM hearing today on rising drug prices.
Read his full testimony here.
Mitchell’s testimony will highlight stories of patients skipping doses and going into debt to afford rising prescription drug prices. And he’ll focus on the fact that right now, nearly 1 in 3 adults report not taking their medicines as prescribed because of the cost. He’ll also discuss three legislative solutions to fix our broken system:
Key Points From Mitchell’s Testimony:
Patients For Affordable Drugs is a national patient organization focused exclusively on policies to lower prescription drug prices. We amplify the voices of Americans struggling under crushing drug prices to make policymakers and elected officials see the heavy toll of high-priced drugs. Patients For Affordable Drugs does not accept contributions from any organizations that profit from the development or distribution of prescription drugs.
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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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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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WASHINGTON, D.C. — It’s easy to get lost in the day-to-day shuffle, but at the end of this week, one fact is undeniable: Big Pharma is on the run. Over the last week, Washington took meaningful steps on legislation that would curb drug company price gouging, end abuse of citizen petitions, stop drug companies from abusing the patent system, demand more transparency from pharmacy benefit managers, and protect people who are insulin dependent.
“At the end of this week, it’s undeniable that the momentum lies with patients working to fix our broken system,” said Ben Wakana, Executive Director of Patients For Affordable Drugs Now. “Drug corporations reach into the pockets of hardworking Americans through dirty tactics like evergreening, pay-for-delay deals and unfair price gouging — and it’s time it ends. The fact that both parties are coalescing around this issue should terrify the greedy executives running drug corporations.”
BIPARTISAN LEGISLATION CONSIDERED THIS WEEK WOULD:
END CITIZEN PETITION ABUSE: Brand-name drug makers were behind 90 percent of all citizen petitions filed between 2011 and 2015 –– all aimed at blocking cheaper generic drugs. The FDA denied more than nine of every 10 petitions. The Ensuring Timely Access to Generics Act, introduced yesterday, would give the FDA the ability to reject citizen petitions if it determines the purpose of the petition is to delay generic drug entry.
Lead Sponsors: Senators Bill Cassidy (R-LA), Cory Gardner (R-CO), Jeanne Shaheen (D-NH), and Michael Bennet (D-CO)
STOP DRUG COMPANY EVERGREENING: Drug corporations make tiny changes to their products in order to extend patent protections and stall cheaper generic options from hitting the market. Introduced yesterday, the REMEDY Act would address evergreening by rooting out non-innovative patents filed by brand drug corporations.
Lead Sponsors: Senators Bill Cassidy (R-LA) and Dick Durbin (D-IL)
CLOSE AN INSULIN LOOPHOLE: The FDA is in the process of recategorizing insulin as a biologic. The Protecting Access to Biosimilars Act, introduced Thursday, would ensure recategorized insulins do not receive an extra 12 years of market protections. That would mean less-expensive insulins could come to market sooner, giving patients relief.
Lead Sponsors: Senators Bill Cassidy (R-LA) and Tina Smith (D-MN)
CURB DRUG COMPANY PRICE GOUGING: Currently, drug corporations can raise prices without notice or justification. Language included in the Prescription Drug STAR Act would require drug manufacturers provide written justification for price increases at least 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. The bill passed out of the House Ways & Means Committee unanimously on Tuesday.
Lead Sponsors: Rep. Richard Neal (D, MA-01) and Kevin Brady (R, TX-08)
INCREASE PBM TRANSPARENCY: Pharmacy Benefit Managers –– the drug middlemen who are supposed to operate on behalf of patients –– are a black box. PBMs negotiate drug discounts, but the public doesn’t know how much, if any, of the rebate reaches patients and consumers. Language passed unanimously by the House Ways and Means Committee on Tuesday as part of the Prescription Drug STAR Act would make information on PBM rebates public on HHS’ website. The information would include, by drug class, the aggregate amount of rebates, discounts, or price concessions that are passed through to the plan sponsor.
Lead Sponsors: Rep. Richard Neal (D, MA-01) and Kevin Brady (R, TX-08)
BONUS (from last week, but still):
PROTECT AMERICANS FROM PAYING MORE THAN OTHER COUNTRIES: Americans pay two times more for prescription drugs than citizens in other developed countries. The Transparent Drug Pricing Act, referred to the Senate HELP Committee April 1, would ensure the list price for prescription drugs does not exceed the lowest retail list price for the drug among Canada, France, the United Kingdom, Japan, or Germany.
Lead Sponsors: Senators Rick Scott (R-FL) and Josh Hawley (R-MO)
RESTRICT SHADY PAY-FOR-DELAY DEALS: 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 1499, the Protecting Consumer Access to Generic Drugs Act, which passed unanimously out of the Energy and Commerce Committee last week, 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.
Lead Sponsor: Rep. Bobby Rush (D, IL-1)
END 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 which passed unanimously out of the Energy and Commerce Committee last week 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.”
Lead Sponsors: Representatives David Cicilline (D, RI-1), James Sensenbrenner (R, WI-5), Jerry Nadler, (D, NY-10), Doug Collins (R, GA-9), Peter Welch (D, VT-At Large), David McKinley (R, WV-1)
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BOSTON — Massachusetts patients will speak out against high drug prices tomorrow during testimony in favor of sweeping state reforms that would require drug corporations to justify exorbitant prices and give the state negotiation power on behalf of patients and taxpayers. Patients For Affordable Drugs Now, a Washington, DC-based bipartisan patient advocacy organization that takes no money from the pharmaceutical industry, is helping patients share their drug pricing stories in Massachusetts, sending two patients to testify before the Joint Committee on Health Care Financing tomorrow and publishing a raft of patient stories on its website to underscore the urgency of the drug pricing crisis in Massachusetts.
“Drug corporations have a direct line into Massachusetts’ state coffers and patients’ pockets, and it’s time for the legislature to act,” said David Mitchell, a cancer patient and the founder of Patients For Affordable Drugs Now. “We’ve heard from 265 Bay staters who are suffering under relentless prescription drug price hikes. We applaud Gov. Baker, 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.”
HB 1133 and SB 706 would:
Testifying at tomorrow’s hearing are:
Mary Mack of Nantucket: Mary lives with advanced heart failure due to a rare type of genetic muscular dystrophy. The symptoms of her disease—fatigue and shortness of breath—make it difficult to accomplish even the simplest task. Mary was on Entresto for only five months when the copay went up to $225 a month. The expense became too much for her family, so she stopped taking the drug.
Helen Fonseca of Tewksbury: Helen faces Crohn’s Disease. She plans to tell lawmakers: “I take Apriso. Before I retired, this drug cost $60 for a three-month supply. However, once I retired three years ago, the cost skyrocketed, going up to $500 for the same supply. There is no generic for this drug, even though its patent has run out. This cost is absurd. And for people like me who are on a fixed income, this cost is often impossible to pay.”
MORE PATIENT PERSPECTIVES:
Kathleen Rider, Otis, MA: “I am on a fixed income and am forced to shell out $145 for the medication every three months. It adds up. The stress of having such a costly medicine does affect my mental health. This is a necessary medication for me.”
Diane Sarmento, Lowell, MA: “I am a Medicare patient who was prescribed Ampyra, which is meant to strengthen my muscles and improve my overall quality of life. But the price of this drug is prohibitive: when I can’t get assistance, I can’t afford it.”
John Wood, West Springfield, MA: “I have type 2 diabetes that I work to keep at bay by living a healthy lifestyle. However, I also take Onglyza to help maintain my A1C levels. I usually fall into the Medicare donut hole within 6 months, causing a coverage gap. That’s when the price skyrockets to upwards of $450.”
According to recent polling from the Kaiser Family Foundation, only 25 percent of Americans say they trust drug corporations to price their products fairly. Nearly one in four Americans report difficulty affording their prescription medications.
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