Bills by Congresswoman Abigail Spanberger seek transparency in pricing and clearing hurdles for cheaper generics.
No matter where Congresswoman Abigail Spanberger (D-VA) goes, there’s one thing she routinely hears about from her constituents.
“I can be pretty much anywhere, and someone will take a moment to tell me their story about prescription drug pricing,” Spanberger said. “We can be at a beautiful outdoor festival and someone will clasp both my hands and say ‘We need help. We can’t afford my husband’s insulin.’”
“It’s constant. It’s a constant worry that people have. It’s their economic stability; it’s their health stability and depending on the type of medication; it’s their ability to keep themselves alive or keep their child alive, and that is so basic and so fear inducing and it’s pervasive. It never, never leaves them.”
The former-CIA-agent-turned-congresswoman continued her push to lower drug costs in late October when she introduced the bipartisan Biologic Patent Transparency Act, a bill she says would increase access to lower-cost prescription drugs and prevent pharmaceutical companies from blocking generic alternatives from entering the market.
Between 2008 and 2016, the price of brand-name oral prescription drugs rose nine percent annually, while injectable drugs increased by 15 percent annually, according to a 2019 study published in Health Affairs.
These costs are often passed to patients: Americans spent $535 billion on prescription drug costs in 2018, a 50 percent increase since 2010, according to a 2018 estimate from Pew Charitable Trusts.
Behind the costs
Research indicates the surge in drug costs has been largely driven by one class of drugs: biologics, advanced therapies derived from living organisms that can be used to treat diseases and conditions such as cancer, diabetes, and autoimmune diseases.
Less than two percent of all Americans use biologics, but they represent 40 percent of total spending on prescription drugs, according to Dr. Scott Gottlieb, a former commissioner of the Food and Drug Administration. Since 2014, biologic drugs account for 93 percent of the increase in drug spending, according to data from the IQVIA Institute.
“Something is really wrong, and we’ve got to get ahead of this before the prices become so prohibitive,” Spanberger said.
The congresswoman believes biologic prices remain high because the manufacturers that have cornered the market on these expensive drugs have stifled competition from biosimilars, the generic lower-costing alternatives to biologics.
“Something is really wrong, and we’ve got to get ahead of this before the prices become so prohibitive.”
Gottlieb, who left his post at the FDA in April 2019, believes this lag is owed in large part to the efforts of biologics manufacturers, who have been accused of conducting a misinformation campaign against biosimilars. “I am worried that there are either deliberate or unintentional efforts by branded companies to create confusion” about the safety and effectiveness of unbranded biologic drugs, Gottlieb said in a January 2019 interview with the Washington Post.
Spanberger argues that manufacturers have also taken advantage of America’s complicated patent system to prevent competition — an issue she aims to tackle through her legislation.
“The purpose and the focus of this bill is to ensure that patents are in fact respected,” Spanberger said. Spanberger’s bill would require companies to publicly disclose the web of patents that protect their biologics, making it easier for competitors to study them and develop their own generic versions of these drugs—theoretically lowering drug prices for American patients.
A 2018 study from the nonprofit Rand Corporation found that the availability of biosimilars would result in significantly less spending on biologic drugs. The study found that biosimilars would save an estimated $54 billion in healthcare spending from 2017 to 2016. A 2014 survey from Express Scripts estimated $250 billion in savings from 2014 to 2014 from just 11 biosimilars expected to be approved and marketed. According to the FDA’s analysis, if approved biosimilars had been available in the US, Americans could have saved more than $4.5 billion in 2017.
“For many of our neighbors, expanded access to lifesaving generic alternatives like biosimilars would help lower costs and give them new peace of mind,” Spanberger said in a statement last week.
Spanberger introduced the bill alongside Rep. Tom Reed (R-NY). “It was very important for me that I partner with a Republican and that we use this to find a commonality that we say this shouldn’t be a political issue,” she said.
Spanberger believes it’s an issue bridges party lines. In August, she met a family at a roundtable event whose experience highlighted the seriousness of the issue.
“One of the families there, a diabetic family, they were talking about how they stack the way they fill prescriptions for the parent, who is diabetic, and for the child, who is diabetic, in order to try and optimally save money, because they can’t afford to pay for all of the prescriptions at once… And these are just not choices or efforts that families should have to go through just to get something a simple as inulin,” Spanberger said.
Pharmacists and patients
Spanberger also explained how the cost of prescription drugs has changed relationships between pharmacists and patients.
“We also had pharmacists who work for small, family-owned pharmacies and they were talking about the experience of being the person behind the counter who is choosing not to fill the prescription because they suspect, based on the price, that the patient who received the prescription likely won’t come and pick it up,” Spanberger said.
This scenario isn’t an anomaly; in 2016, more than one-in-four Americans ages 16 to 64 stopped taking their prescription medication because they could no longer afford to.
While there is no timeline for a vote on her biologics bill, her proposed legislation to increase transparency surrounding the role of pharmacy benefit managers in negotiating drug prices passed the House on October 28 by a unanimous, 403-0 vote and now heads to the Senate.
“Everybody sees that prescription drug pricing is going up, but nobody can really say why. We hear, ‘Oh it’s research, oh it’s this, oh it’s that,’ but there isn’t really any clarity,” Spanberger said.
While Spanberger’s focus on addressing rising drug costs has been largely driven by her constituents, she’s also experienced the issue firsthand. She recently chose not to pick up a prescription from her dermatologist after she learned it cost $300.
“That’s a minor case. It’s not a big deal and I’ll be just fine with over-the-counter medication,” she said. “But what if that’s a more life-saving or necessary medication?”