Welcome to Overnight Regulation, your daily rundown of news from the federal agencies, Capitol Hill, the courts and beyond. It’s Tuesday evening, and it’s been a newsy day (aren’t they all?). President Trump fired Secretary of State Rex Tillerson and replaced him with CIA Director Mike Pompeo.
THE BIG STORY:
The House failed to pass “right to try” legislation on experimental drugs Tuesday evening after Democrats expressed safety concerns over how the measure would let patients bypass the Food and Drug Administration (FDA).
In a vote of 259-140, the bill fell short of the necessary two-thirds support to send it to the Senate. The House had voted for the measure under suspension of the rules.
Despite the bill’s failure Tuesday, House Majority Leader Kevin McCarthy (R-Calif) said in a statement that “the House will not let this be the end.”
“We will try again, pass legislation, and bring hope to those whose only desire is the right to try to live,” he said.
“Right to try” is a priority for the White House, and Republican leaders on the House Energy and Commerce Committee unveiled a revised version of the bill over the weekend.
Before the vote, Speaker Paul Ryan’s (R-Wis.) spokeswoman tweeted: “Are Democrats really going to deny critically ill patients every opportunity to find treatment?”
Democrats have countered that the measure provides “false hope” given no requirement in the bill that drugmakers provide the medicines to those who ask.
Breakdown…
What the bill does: It lets terminally ill patients request access to drugs the Food and Drug Administration (FDA) hasn’t yet approved. Notably, those seeking the medicines won’t have to go through the FDA.
Supporters: They say terminally ill patients should have every tool at their disposal to try a drug that could potentially help them, and argue the drug approval process is too lengthy. They note that the medicines must have passed a phase 1 clinical trial and be in the FDA’s pipeline.
Opponents: They worry about safety concerns from taking FDA out of the process. They argue that the agency already has a program to help patients get access to unapproved drugs, where physicians can request to let their patient try an experimental medication. And they’ve said the legislation provides “false hope” because drugmakers aren’t required to give patients the unapproved drugs if they ask.
I have the story here.
ON TAP FOR WEDNESDAY
The Senate Judiciary Committee holds a hearing on improving school safety after the mass shooting at a Parkland, Fla., high school.
The House Oversight and Government Reform Committee holds a hearing, titled “Shining light on the federal regulatory process,” to access how agencies comply with rulemaking and guidance requirements.
A House Financial Services subcommittee holds a hearing on cryptocurrencies and the market for initial coin offerings (ICOs).
The House Natural Resources Committee marks up six bills on national monuments and land use.
REGULATORY ROUNDUP:
Finance: Rep. Jeb Hensarling (R-Texas), chairman of the House Financial Services Committee, said he’s not holding talks with key senators on making changes to a banking bill set to pass the Senate this week.
The Senate bill faces opposition from House conservatives who want the measure to include more input from the lower chamber.
K Street sources told The Hill that the bill faces a growing chance of dying in the House unless senators agree to go to a conference with the House.
Hensarling said he expects a conference to be formed, and repeated his call for the Senate to include in its legislation some of the more than two dozen bills his committee passed with bipartisan support.
A spokeswoman for Senate Banking Committee Chairman Mike Crapo (R-Idaho) declined to comment on whether he’d be willing to conference with the House.
House conservatives have long been skeptical of the Senate package, which they say doesn’t go far enough to rein in the Dodd-Frank Wall Street reform law.
While they’ve warmed to striking a deal with the Senate, they’ve insisted on adding more of their own measures to the legislation.
Environment: Environmental Protection Agency (EPA) head Scott Pruitt says that when it comes to determining new federal vehicle emission standards, California can’t set the rules for the rest of the country.
“California is not the arbiter of these issues,” Pruitt told Bloomberg News Tuesday.
California “shouldn’t and can’t dictate to the rest of the country” what those emissions levels should be, he added.
The Golden State currently regulates its greenhouse gas emissions at the state level. In the past, California and other states have implemented higher emissions standards than federal levels thanks to a waiver program under the Obama administration.
The Trump administration has now set an April 1 deadline to determine whether it will revise federal vehicle emissions standards for 2022 to 2025.
In January, Pruitt said he supported a national fuel standard, sparking speculation he would do away with the waiver system.
Environment: Dozens of House Democrats are asking Interior Secretary Ryan Zinke to halt all trophy hunting import decisions for elephants and other species, expressing “deep concern” over the administration’s policy.
The 55 lawmakers, led by House Natural Resources Committee Ranking Member Raúl Grijalva (Ariz.) and Rep. Don Beyer (D-Va.), complained in a Tuesday letter that Interior’s decision to consider trophy import licenses on a “case by case” basis reduces transparency and accountability and will allow more imports of animal parts into the country.
The Democrats expressed “deep concern about the continued misguided approach the Fish and Wildlife Service (FWS) is taking regarding the trophy killing of elephants and lions in African countries and the negative implications it has for this imperiled wildlife.”
The letter is the latest opposition, from members of both parties, to FWS’s decision to repeal a host of species-wide determinations about trophy hunting imports. Such policies must be based on what would help species conservation. Officials now plan to evaluate each import application individually.
Energy: Interior Secretary Ryan Zinke said he decided to exempt Florida from a plan to expand offshore drilling because the state is “different” compared to other states.
Speaking to the Senate Natural Resources Committee about the Interior Department’s proposed fiscal 2019 budget Tuesday, Zinke said his announcement in January to remove Florida from the list of coastal states that might see expanded drilling is due to a unique variety of factors affecting the state.
“Now, Florida’s different for three reasons. One is that every member, both sides of the aisle, wrote me an immediate letter, said, ‘We don’t want it,’ ” Zinke said responding to a question for Sen. Angus King (I-Maine) on why Florida was exempt and Maine was not.
“Second is your governor. Governor of Maine is for it. And third, Florida has a federal moratorium in place until 2022, which no other state has.”
Zinke added that he initially left Florida on the list of state waters under consideration for drilling because otherwise “it would have been arbitrary and capricious.” But he added that the final decision on Florida was “still in the process.”
Miranda Green reports.
Health care: Urgent action is needed to address the rising cost of cancer drugs, a White House advisory panel said Tuesday.
“Cancer patients should not have to choose between paying for their medications or paying their mortgages. For so many, it is truly a matter of life and death,” said Barbara Rimer, chair of the President’s Cancer Panel, which advises the president on issues related to cancer policy.
“This is a national imperative that will not be solved by any one sector working alone.”
Cancer drugs can enter the market with a price tag of more than $100,000 a year, meaning thousands of dollars in out-of-pocket costs for patients. The White House panel noted that the prices of many drugs don’t reflect their value or health benefit.
Jessie Hellmann has the story.
More health care: Shareholders on Tuesday overwhelmingly approved CVS’s proposed $69 billion deal to acquire health insurer Aetna.
The agreement was approved by about 97 percent of Aetna shareholders and 98 percent of CVS shareholders.
The merger is expected to close in the second half of this year, pending regulatory approval by the Justice Department. If approved, the merger of the nation’s largest pharmacy and third-largest health insurer could have major implications for the industry.
Technology: A group of major companies including Disney, IBM and Oracle is urging the Senate to pass an online sex trafficking bill despite opposition from some internet firms.
In a letter to Senate leaders on Tuesday, the companies, which have all been odds with internet giants in the past, argued that the bill is necessary to crack down on the online sex trafficking trade.
“As responsible U.S. companies, we believe it is time to address this urgent problem,” reads the letter obtained by The Hill.
“This legislation has been thoughtfully and carefully shaped through the legislative process to provide limited, controlled exceptions to the [Communications Decency Act] immunity provision that will help policymakers, law enforcement, and victims combat this illicit criminal activity.”
The letter was also signed by Home Depot, Hewlett Packard and 21st Century Fox.
The Allow States and Victims to Fight Online Sex Trafficking Act (FOSTA) would make it easier to go after websites for facilitating sex trafficking by cutting the broad legal protections they currently enjoy under Section 230 of the Communications Decency Act.
Harper Neidig has the details.
More health care: A federal judge has thrown out a lawsuit by the Massachusetts attorney general challenging the Trump administration’s rollback of ObamaCare’s birth control requirements.
U.S. District Judge Nathaniel Gorton said the state lacks standing to sue because it already requires that employer health plans cover contraception regardless of changes in federal policy.
The Trump administration in October issued a rule allowing for-profit and nonprofit employers and insurers to stop covering birth control if they had moral or religious objections.
Massachusetts was one of several states that sued over the changes.
Jessie reports
Environment: The Environmental Protection Agency (EPA) will finish the process of reviewing hundreds of damage claims related to the 2015 Gold King Mine spill in Colorado by the end of the month.
EPA Administrator Scott Pruitt told The Denver Post about the timeline Monday, saying the agency will have reviewed about 400 claims from Colorado, Utah, New Mexico and the Navajo Nation.
The Obama administration rejected about 70 of those claims, arguing that the government’s sovereign immunity means it cannot pay them, though the administration did pay millions of dollars to various parties injured by the spill. Pruitt promised early in his career to review the rejected claims.
“This agency, and more particularly the U.S. government, caused harm to citizens in Colorado, New Mexico and Utah and it had not taken steps to address that,” Pruitt told the Post.
Transportation: Democratic Sen. Heidi Heitkamp (D-N.D.) is pressing the Department of Transportation for clarity over a new rule requiring truckers to electronically log their hours.
In a Tuesday letter to Transportation Secretary Elaine Chao, Heitkamp said she is worried that agricultural stakeholders have not had enough input in the administration’s efforts to impose the rule.
“Based on feedback I have received from my constituents, I am very concerned that this rule does not take into consideration the realities of transporting livestock, insects and perishable produce, and that it will affect recreational horse users that are not involved with the commercial trucking industry,” Heitkamp wrote.
The new rule, which mandates truckers use electronic logging devices rather than paper to record driving hours, went into effect Dec. 18. But the administration gave truckers until April 1 to comply with the requirement, which is meant to adhere to hours-of-service rules and help improve safety.
Heitkamp in her letter said there is “uncertainty” surrounding whether or not the rule applies to “agriculture and recreational uses” like transporting cattle for rodeos.
Mallory Shelbourne has more here.
Courts: A federal judge has struck down as unlawful a Maryland high school’s policy preventing a transgender student from using the boy’s locker room.
U.S. District Judge George L. Russell III found that the policy blocking transgender teen Max Brennan from using the boy’s locker room unlawfully singles him out and “harms his health and well-being,” The Washington Post reported on Tuesday.
Brennan, 15, had been required to use to a separate gender-neutral bathroom at St. Michaels Middle High School to get ready for his gym class, which caused him at times to either be late or be disciplined for not changing for the class.
IN OTHER NEWS
Digital currency sales face rocky path with more regulatory focus — Reuters
Another exchange jumps on bitcoin bandwagon — The Wall Street Journal
House panel probes organization that accredits most US hospitals — The Wall Street Journal
Winklevoss twins propose self-regulatory body for cryptocurrency industry — Marketwatch
FCC must defend net neutrality repeal in court against dozens of litigants — Ars Technica
China unveils shake-up of bank regulation to rein in credit spree — The Guardian
Industry worried about regulatory backlash after unauthorized satellite launch — SpaceNews