BOSTON >> U.S. Sen. Elizabeth Warren and U.S. Rep. Katherine Clark, both Massachusetts Democrats, introduced a bill to Congress on Wednesday that would allow for the partial filling of opioid prescriptions, a strategy being explored by state lawmakers to reduce the number addictive painkillers in circulation.
The legislation would allow prescribing physicians or patients to request a partial fill of an opioid prescription with remaining portions of the prescription available to patients at a later date so long as the it is retrieved before the initial prescription was due to be "exhausted."
"Tackling the opioid abuse epidemic will be tough, but we can take an important step by reducing the number of pills in circulation. This bipartisan bill will empower patients and doctors to work together to determine appropriate pain treatment, while limiting the number of unused pills left in family medicine cabinets," Warren said in a statement.
Meanwhile, U.S. Sen. Edward Markey warned Wednesday that the opioid abuse epidemic would continue without a change in direction at the Food and Drug Administration, which he blamed for authorizing the use of so-called abuse-deterrent opioids without proper review and in the face of concerns raised by medical professionals.
"We will not solve the prescription drug crisis with an FDA that operates with business as usual and continues to turns its back on external experts. The FDA is supposed to be our nation's pharmacist, but right now, it is prescribing dangerous and addictive opioid painkillers without limits, without supervision and without consequence. The FDA needs to welcome outside expert advice and must convene expert advisory committees for all opioid approval decisions," Markey said.
State lawmakers are negotiating legislation that similarly aims to reduce the number of addictive opioids in circulation. The Baker administration has said that in 2014 doctors in Massachusetts wrote 4.6 million prescriptions for opioids totaling more than 255 million pills to a population of just over 6.7 million people.
The Senate last year passed an opioid abuse prevention bill that included a provision pushed by Quincy Sen. John Keenan to allow for the partial filling of opioid prescriptions, despite concerns that the strategy might run afoul of federal law.
The original bill proposed to allow individuals to take out their prescriptions for schedule II narcotics, which includes drugs like Oxycontin, in smaller batches over time, but still adding up to the total prescription size. That section was ultimately amended in an attempt to comport with federal law to allow a one-time smaller fill at the patient's request, but would require the patient to go back to their doctor in order to receive the balance of the prescription.
Keenan said Wednesday that Warren and Clark's interest in the issue demonstrates a "recognition that there's logic and common sense" behind a partial-fill policy and it "should be done as a national policy."
"I think it's great, but I don't think it should deter us here in Massachusetts from continuing to do what we're trying to do because things don't always happen so quickly in Washington," he said.
Warren and four other senators, including Markey, wrote to the U.S. Drug Enforcement Administration in December seeking either a clarification or a new rule that would expressly allow for the partial filling of Schedule II drug prescriptions, as is already clear for Schedule III, IV and V substances.
The bill filed by Warren and Clark on Tuesday would clear up any regulatory ambiguity by clearly stating that remaining portions of partially filled prescriptions may be filled at a later time, but "must be exhausted prior to, or on the same date that such prescription, if fully filled, would have been exhausted."
Gov. Charlie Baker and the House took a different approach toward limiting the quantity of opioids being prescribed. Baker proposed to limit the amount of pills a doctor could prescribe to a first-time patient to a three-day supply, while the House in a bill it passed in January pushed that to seven days.
Keenan said he'd like to see a limit on first-time prescriptions and his partial-fill language included in any final bill.
"I think they're complimentary actually. I don't think they're exclusive of one another," Keenan said. "The fact that we don't have a bill yet means they're working through it and I just hope they view it as a conference committee of addition because there's a lot of good ideas out there," Keenan said.
The House and Senate bills are now before a conference committee, and Baker said Tuesday he's "optimistic" that a compromise could be struck in the coming weeks before the House turns its attention fully to a debate over the fiscal 2017 budget in April.
"I get the fact that this is complicated and we proposed some pretty disruptive stuff, but I'm more optimistic about this. It's my sense about this that we're likely to see something fairly shortly and unless I get told otherwise I'm going to presume that's going to be the case," Baker said.
The governor sat down on Monday for an interview with Judy Woodruff on PBS's NewsHour after the the National Governors Association winter meetings in Washington, D.C. where the opioid abuse epidemic was a central topic.
During the interview, which aired Tuesday, Baker addressed concerns raised by the national doctors groups about limits on painkiller prescriptions that they consider to be "arbitrary," according to Woodruff.
"My view on this is we need to separate acute pain from chronic pain. There's no reason to give somebody who has their wisdom teeth out 30 pills. There's no reason to give somebody who has a minor procedure 60 pills. The stories I hear about this still as I travel the commonwealth are overwhelming. It's like an avalanche," Baker said.
U.S. Sen. Shelley Moore Capito of West Virginia and U.S. Rep. Steve Stivers of Ohio, both Republicans, co-sponsored the partial-fill legislation.
Markey, who tried to block President Barack Obama's appointee to head the FDA and voted against Dr. Robert Califf's confirmation Wednesday, said he also hopes the federal government will mandate more education for prescribers and hold pharmaceutical companies responsible for the drugs they bring to market.
"As the Senate prepares to debate comprehensive substance abuse legislation, I am committed to strengthening the bill so that it puts in place real protection for the American people. That includes mandating education for anyone who prescribes opioid painkillers, expanding access to lifesaving medication-assisted therapies, and holding Big Pharma accountable for the consequences of opioid painkiller addiction," Markey said.