SALEM, Ore. — Oregon patient advocate Joanna Olson will testify today in front of the Oregon House Health Care Committee in support of Senate Bill 764, which would crack down on abusive “pay-for-delay” deals between pharmaceutical manufacturers that delay generic competition and keep drug prices high.
Olson, a retired grandmother in Beaverton, suffers from a blood clotting condition. She is prescribed Eliquis, which costs her $430 for a month’s supply. “Every time I pick up the prescription, I think about leaving without the drug,” Olson, 86, will explain.
Eliquis wasn’t always this expensive — the company that makes it has hiked the price every year since 2013, nearly doubling the price during that time.
“Pharmaceutical companies set exorbitant prices while simultaneously blocking generic competition simply because they can,” Olson will say to the committee. “A common medicine needed by millions, like Eliquis, shouldn’t break the bank for seniors like me who live on a fixed income. I urge you to vote in support of Senate Bill 764 to bring much-needed relief to patients across our state.”
SB 764 would prohibit an anti-competitive drug industry tactic called “pay-for-delay,” in which a brand-name drug maker cuts a deal with a generic company to delay the introduction of a lower-priced drug to market. The bill would also allow the Oregon attorney general to bring civil action against companies involved in such deals, with penalties up to three times the value of the drug or $10 million (whichever amount is greater).
Oregon patient advocate Michael Nielsen testified in front of the Senate Health Care Committee in support of SB 764 in March. Nielsen’s wife, Jacki, was diagnosed with the potentially fatal disease hepatitis C, and her medication is priced at more than $13,000 — or $433 per pill.
The hearing and Olson’s testimony can be watched here at 3:15 PM PT.
###
SALEM, Ore. — The following statement was issued by Sheila McLean, a patient and the executive director of Patients For Affordable Drugs Now, after the Oregon Senate passed SB 764, which cracks down on abusive “pay-for-delay” deals between pharmaceutical manufacturers that delay generic competition and keep drug prices high:
“Oregonians have been suffering from high drug prices at the whim of Big Pharma for far too long. SB 764 would rightfully prohibit pharmaceutical companies from rigging the system to delay less expensive, generic medications from coming to market. This legislation would finally give Oregonians the access to less expensive prescriptions they desperately need. On behalf of patients, we urge the Oregon House to move quickly to pass this bill.”
Background:
###
SACRAMENTO, Calif. — A groundbreaking bill to lower prescription drug prices will move to the full Assembly floor. Assembly Bill 824 would stop Big Pharma from cutting deals that block less-expensive generic drugs for state residents — a tactic that limits patient choice and costs taxpayers billions each year.
AB 824 would:
“California residents have been speaking out in support of the state’s effort to stop Big Pharma from cutting anti-competitive deals that keep drug prices high,” said Juliana Keeping, Communications Director for Patients For Affordable Drugs Now. “Thanks to a dirty tactic called ‘pay-for-delay,’ drug corporations are allowed to pay off generic competitors in an effort to maintain their monopoly and increase prices for patients. California patients have had enough and are sending a simple message: Drugs don’t work if people can’t afford them.”
Here’s what California patients speaking out about the need to lower drug prices have to say:
Dorothy Nerli, Willows, CA: “I find I am faced with increased costs, like the time my Spiriva went up to $129. Spiriva helps to clear my airways, clearing out my lungs in order to make my breathing easier. I have scar tissue in my lungs due to several bouts of pneumonia. This is a horrible case of greed on the part of the manufacturers, who should lower the price of these medications. It shouldn’t cost seniors their rent or a healthy diet in order to be able to breathe.”
Elizabeth Reinboldi, Vacaville, CA: “If I weren’t able to get my medication, it would be a great detriment to my quality of life. I love to be involved with my church and volunteer as much as possible. I wouldn’t be able to do these things if I couldn’t get my medicine, or if the price goes up at all. I simply wouldn’t be able to walk due to the pain. We need lower drug prices as soon as possible.”
Sharon Fisher, Rio Vista, CA: “Because of the high price, my doctor put me on a cheaper drug: Tramadol. It does not work as well as the Lidocaine. I don’t get to do any of the activities that I used to love. I miss going to the gym and leading an active lifestyle, but my pain is simply too severe. Too many seniors have to go without medicine due to high out of pocket costs. Something needs to change –– and soon.”
Patients For Affordable Drugs Now is a Washington, DC-based patient advocacy organization that takes no money from the pharmaceutical industry or any other player in health care. As part of its ongoing campaign in support of the California legislation, Patients For Affordable Drugs Now:
###
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.
###
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 1162, LD1272, LD 1387, LD1499)
California (AB 824)
Maryland (HB 768)
Massachusetts (HB 1133, SB 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.”
###
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)
###
SACRAMENTO, Calif. — A first-in-the-nation California bill would stop Big Pharma from cutting deals that block less-expensive generic drugs for state residents — a tactic that limits patient choice and costs taxpayers billions each year. Californians have written hundreds of letters in support of Assembly Bill 824, which is being heard in the judiciary committee this week. The bill also received an endorsement today from Patients For Affordable Drugs Now, a Washington, DC-based patient advocacy organization that takes no money from the pharmaceutical industry or any other player in health care. The organization launched a 5-figure campaign to advance the bill.
“Big Pharma is reaching into the pockets of hard-working Californians through dirty tactics like pay-for-delay deals that block cheaper generic drugs,” said David Mitchell, a cancer patient and the founder of Patients For Affordable Drugs Now. “We’ve heard from more than 1,000 Californians who report struggling to afford skyrocketing prescription drugs. All the while, Big Pharma’s profit margins are soaring while players collude to cut monopolistic deals. AB 824 could put an end to this egregious scheme that’s gone unchecked for far too long.”
AB 824 would:
Patients For Affordable Drugs Now’s 5-figure campaign includes digital ads to give Californians tools to contact their representatives in support of the legislation through letter writing and phone calls.
###
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.”
###