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)
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.
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.”
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.