Big Pharma lobbying rises as firms defend costly biologic drugs

By James McNair
Kentucky Center for Investigative Reporting

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 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, 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.

“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. 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.”

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.

UPDATE, March 4: The Kentucky Pharmacists Association says the notice requirement would discourage patients from accepting biosimilars. Senate Majority Whip Jimmy Higdon of Lebanon “supported the KPhA position and cast the lone opposing vote Wednesday,” March 2, when the Senate sent the bill to the House on a 36-1 vote.

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.

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