Two months before election, Gus Bilirakis tries to tweak flawed opioid law he backed

On Sept. 5, two months before Election Day where he's running for a seventh term, U.S. Rep. Gus Bilirakis filed a bill to clarify a 2016 law he co-sponsored that made it nearly impossible for the Drug Enforcement Administration to intercept suspicious shipments of prescription drugs.

For 40 years, the DEA had authority to halt shipments that posed "an imminent danger" to the public. The new law in 2016 made the DEA prove a "substantial likelihood of an immediate threat," a far higher bar that gave drug companies a freer reign as the opioid crisis ravaged the nation.
Now Bilirakis' bill offers a change the Department of Justice requested, which would allow the DEA to freeze sketchy shipments based on "probable cause" of an immediate threat.
But two irreversible things occurred between when the drug industry's lobbying for the original law heated up in 2014 and Bilirakis' change of heart:
Bilirakis, a Republican from Palm Harbor, accepted $40,000 from the same drug companies Florida Attorney General Pam Bondi would later say "caused the opioid crisis."
And more Floridians died.

DISTRICT 12 RACE: Bilirakis, Hunter: Where's the money coming from?
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In a lawsuit filed in May against the country's largest drug companies, Bondi said the manufacturers caused Florida's epidemic by misleading patients about the dangers of addiction. Distributors, she said, flooded supplies to customers, reaping "billions of dollars in revenues while causing immense harm."

She filed the lawsuit in Pasco County, in Bilirakis' 12th Congressional District, which had the highest drug overdose death rate in Florida from 2004 to 2012.

A single pharmacy in the tiny Pasco community of Hudson purchased 2.2 million opioid pills in 2011, according to Bondi's lawsuit.

During the rise of the epidemic, the DEA cracked down, sanctioning distributors for ignoring their duty to halt suspicious shipments of pills.
The drug industry responded with an intense campaign lobbying Congress for what would become the 2016 Ensuring Patient Access and Effective Drug Enforcement Act. It stymied the DEA's ability to stop distributors funneling drugs to unscrupulous doctors and pharmacies, a 2017 investigation by The Washington Post and 60 Minutes first revealed.

In 2014 Bilirakis received a total of $9,500 from drug companies who would later be named in Bondi's lawsuit according to Federal Election Commission filings. It was more than double what he ever received in a single year from those companies since taking office in 2006.

Then Bilirakis became one of six co-sponsors of the House version of the bill in February 2015, taking $14,500 from Bondi's defendants that year. He received $7,000 in both 2016 and 2017, and $2,000 so far this year from those companies, according to the election commission.

Beyond companies specifically named in Bondi's lawsuit, Bilirakis received $80,850 overall from the pharmaceutical/health products industry in 2016, according to the Center for Responsive Politics.

Opioid related deaths in Florida hit 5,725 in 2016, a 35 percent hike from 2015, according to the state Medical Examiners Commission. In 2016, Pasco and Pinellas counties had the highest number of oxycodone deaths in the state.

Bilirakis said he had no idea the law, which took effect in April 2016, would hinder the DEA from stopping shady distributors until The Washington Post/60 Minutes investigation published last year.

He said he supported the bill because his office was flooded with calls from seniors and legitimate pain patients who had trouble getting prescriptions filled after Florida cracked down on pill mills and unscrupulous pharmacies and doctors in 2011.

"There's a big issue out there where they're not having access, they're not getting their pain medicine," Bilirakis said in a recent interview. "I thought I was doing something good. No one objected. We studied the bill. All the feedback was good from the DEA and administration."

But Joe Rannazzisi, who led the DEA's Office of Diversion Control from 2005 to 2015, said in an interview with the Tampa Bay Times that he and his staff tirelessly fought every iteration of the bill since Rep. Tom Marino, R-Pa., introduced the first version in 2014. Ranazzisi said he had a conference call in 2014 with staff of the Energy and Commerce Committee, where he recalls saying "there's people dying out there, and what you're going to do is strip us (of) the ability to go after distributors and manufacturers."

Bilirakis has been a member of the Energy and Commerce Committee since 2013.

"If he said he didn't know anything about it, he didn't do his job with the committee," Rannazzisi said.

That call prompted a series of events that led Marino to ask for an inspector general investigation of Rannazzisi's conduct.

Rannazzisi retired from the DEA in October 2015 amid the pressure. The law's loudest critic was then out of the picture. The bill unanimously passed the House and Senate before President Barack Obama signed it into law.
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Former federal prosecutor and FBI agent Chris Hunter, a Democrat, said Bilirakis' "complicity" in the opioid crisis was one factor that motivated him to run against the six-term congressman this year.

As a senior trial attorney with the Department of Justice, Hunter led the prosecution of the owner and associates of A to Z Pharmacy of New Port Richey, which generated more than $100 million from a compounding pharmacy fraud scheme.

"Gus made his choice. He sided with the opioid lobbyists, the same ones funneling money in his campaign bank account," Hunter said. "He took PAC money to do what opioid lobbyists wanted done and now he's trying to cover his tracks. It's too late. The opioid public health crisis has affected families in our community, our state and across the country in deep and profound ways."

DISTRICT 12 RACE: Bilirakis, Hunter debate comes down to one word. Trump.

But not all voices fighting the opioid epidemic hold Bilirakis responsible.
Republican Pasco County Sheriff Chris Nocco, who has called opioid manufacturers and distributors "drug dealers" that were "pushing pills" has endorsed Bilirakis for re-election. Nocco declined an interview request to discuss Bilirakis' role in the legislation.

Bondi, a Republican, also declined an interview request through a spokesman, citing the ongoing lawsuit.

Pinellas County Sheriff Bob Gualtieri, a Republican who endorsed Bilirakis for re-election, notes how after the crackdown on pill mills, he heard outcry from legitimate pain patients unable to fill prescriptions. Addicts moved to street opioids like heroin and fentanyl, convincing him it is addiction, not bad legislation or DEA's inability to regulate, fueling the problem.

"The jury's out," Gualtieri said. "Do these drug manufacturers have skin in this and did they improperly provide incentives and were they capitalizing on this demand and addiction? At the core of all this it's a demand problem driven by addiction, and that's what the drug problem is."
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Despite its wording suggested by the justice department, Rannazzisi said Bilirakis' bill to change the threshold needed to suspend shipments from "substantial likelihood" to "probable cause" of immediate threat would not give the DEA the same check on distributors it had for 40 years with the "imminent danger" standard.

"I still have to show somebody all the way upstream is doing something to an individual person somewhere downstream," Rannazzisi said. "Pharmacy is easy. A doctor is even easier, but how do I show a distributor is an 'immediate threat' to somebody?"

"The only way to fix this problem is to go back to the way it was," said Rannazzisi.

Since his co-sponsoring of the 2016 law, Bilirakis' staff has touted his fight against the opioid crisis.

He pushed for a federal grant that gave Florida $54 million in 2017 for prevention, treatment and recovery services, spokeswoman Summer Robertson said. On Friday, he announced his role in securing $285,000 for substance abuse treatment in Pasco.

Bilirakis considers his Sept. 5 bill, now in committees, to be a "fix" to concerns over the law he hadn't anticipated when he signed on.

"I look out for my constituents, that's the way I am," Bilirakis said. "I go the extra mile for my constituents. If I thought it was going to hurt my constituents, I would never ever sign on a bill like this."

Contact Tracey McManus at tmcmanus@tampabay.com or (727) 445-4151. Follow @TroMcManus.