Drug companies and drug industry groups, flush with money to spend on lobbyists, are flocking to Frankfort like never before.
In just four years, the number of registered lobbyists hired by pharmaceuticals employers has nearly doubled, from 46 in 2011 to 83 today. Their annual spending has more than doubled, to $824,196 in 2015.
“They fight hard at the federal level and they fight hard at the state level,” said Peter Maybarduk, director of global access to medicines at Public Citizen, a nonprofit public advocacy group in Washington, D.C. “Collectively, the pharmaceuticals and healthcare industries spend even more on lobbying than the military industrial complex. They’re tremendously powerful.”
What brings Big Pharma to Kentucky in 2016 is a state Senate bill that would allow pharmacists to dispense interchangeable versions of biologic drugs, or drugs made from living tissue. Name-brand biologics, used to treat arthritis, cancer and psoriasis among other things, are heavily advertised and can cost thousands of dollars per month. Express Scripts, the pharmacy benefits manager, estimates that while biologics accounted for only 1 percent of all prescriptions in 2014, they accounted for 32 percent of all prescription-drug spending.
Interest in cheaper substitutes is high. Already 18 state legislatures have passed biologics-substitution bills. Another 11, including Kentucky, have bills before them.
The irony is that the U.S. Food & Drug Administration has yet to approve a single biologic substitute that meets the federal test for interchangeability. In other words, a new Kentucky law would have no immediate benefit.
The drug industry is pushing for legislation anyway. Brandishing its preferred legislative language and lobbyists, the industry appears anxious to see the bill enacted. At least nine drug companies and groups have stated an interest in the Senate bill, according to the Kentucky Legislative Ethics Commission. Three are interested in that alone.
One group making its lobbying debut in Kentucky is the Biotechnology Innovation Organization (BIO), which represents companies that develop new biologic drugs. It has six lobbyists, including one of its own and five from Top Shelf Lobby in Frankfort. BIO spokesman George Goodno said it hired Top Shelf to “keep an eye on” the bill introduced by Sens. Ralph Alvarado, R-Winchester, and Reginald Thomas, D-Lexington.
“Generally speaking, BIO isn’t going to draft a piece of legislation and hand it to a legislator. That’s not really how it works,” Goodno said. “We do provide them materials such as our principles document and say, ‘This is BIO’s position, and we feel that any bill that goes forward should represent these positions.”
As in other states, the Kentucky bill would give doctors and patients the option of sticking with name-brand drugs. Thomas said he was driven by consumer interests when he co-sponsored the Kentucky bill.
“What I’m really trying to do is make our total health care system as affordable and as cost-effective as other states are doing,” Thomas said. “I sure don’t want Kentuckians who could receive the same type of medication through a biosimilar to not have that option because we haven’t passed such a law.”
Because they are made from living tissue, biologic drugs differ from conventional drugs. Some of the most common are Humira and Remicade for arthritis and Enbrel for psoriasis. Biosimilar drugs are clinically similar to biologic drugs, but aren’t necessarily “interchangeable.”
The FDA has approved only one biosimilar to date -- Zarxio, for certain cancer patients, last March. It was not designated as “interchangeable.”
While the FDA approves drugs, state laws let pharmacists dispense generic drugs. The proposed Kentucky law would allow them do the same with interchangeables.
One of the main hangups, though, is an industry-backed requirement that pharmacists tell doctors that they’ve switched patients to biosimilars. Opponents in other states say it would have the effect of casting doubt on the advisability of a switch. In California, for example, Gov. Jerry Brown embraced that concern in 2013 and vetoed a biosimilars-substitution bill that the legislature had passed with the notification requirement.
That requirement is contained in the Kentucky bill, but Sen. Jimmy Higdon, the majority whip from Lebanon, filed an amendment to eliminate it. He said pharmacists aren’t required to notify doctors when they switch people to generic non-biologic drugs. The Kentucky Pharmacists Association says the communication requirement would discourage substitution to cheaper meds and would compound pharmacists’ workloads.
“We’re just saying, ‘Keep it simple,’” said KPhA Executive Director Bob McFalls. “Pharmacies are already providing this information when they’re processing a claim -- into the pharmacy record, to the benefit manager and the health plan. We just want to stop the process of having to contact the physician and slowing down the process of doing business and serving the patient.”
Doctors, meanwhile, would like more than mere notification of switches to interchangeables. The Kentucky Medical Association, in a letter to the General Assembly, said pharmacists should be allowed to dispense a substitute only when doctors authorize it or don’t forbid it.
Maybarduk, of Public Citizen, said his group and others want laws and standards that foster competition and, therefore, lower-priced options to biologics.
“It is premature for state legislatures to second-guess the FDA’s judgment by passing laws requiring special warnings for interchangeable products that do not yet exist,” Maybarduk said.
Thomas said drug industry lobbyists have “come to see me” about the bill. The same goes for Higdon, whose amendment to throw out the communication requirement is now under consideration by Senate leadership. “It’s very high-profile,” he said. “There’s a lot of discussion of the bill from multiple lobbyists.”
What nags Higdon as much as anything is the urgency to pass the bill. Biosimilar drug substitution, he said, is a complex topic undergoing national debate. Moreover, the absence of any FDA-approved interchangeable biosimilars means that a Kentucky law allowing pharmacists to dispense them would have no immediate effect.
“It’s the kind of bill that should be discussed,” Higdon said. “This whole thing is very complicated and futuristic, and a lot of people are talking to us about passing this. I just want to err on the side of caution. It doesn’t need to be fast-tracked. We need to do it right.”
Reporter James McNair can be reached at email@example.com and (502) 814.6543.