FDA

‘Right to Try’ Bill Could Face Slower Action in House
Changes to measure possible during Energy and Commerce markup

Wisconsin Sen. Ron Johnson’s "Right to Try" legislation faces an uncertain future in the House. (Tom Williams/CQ Roll Call file photo)

A Senate-passed bill intended to help dying patients access experimental drugs will likely face lengthier deliberations in the House. While the Senate fast-tracked the bill on Aug. 3, the House will likely subject it to a hearing and markup before bringing it up to a vote, according to congressional aides and a lobbyist.

The bill would reduce some of the paperwork involved in getting access to experimental treatments, and would offer protections to the drug companies who choose to make drugs available outside of a clinical trial. It’s the federal version of “Right to Try” measures that have been passed in 37 states with support from libertarian-leaning Republicans who say the Food and Drug Administration prevents dying patients from getting treatments.

Rand Paul Wants AUMF Debate With Defense Authorization
Kentucky Republican objected to quick work on McCain’s bill

Sen. Rand Paul objected to taking up the defense authorization Friday. (Bill Clark/CQ Roll Call File Photo)

All eyes were on Arizona Sen. John McCain’s key vote signaling the collapse of the Republican health care bill early Friday morning, but the longtime GOP senator also faced frustration over a delay in turning to the defense authorization bill.

Sen. Rand Paul blocked quick action on the measure, wanting to ensure debate on rolling back authorizations for the use of military force enacted early in the George W. Bush administration.

NIH Contractor Dispute Underscores Agency Conflicts
Agency is trying to change cultural norms that led to 2015 scandal

NIH Director Francis S. Collins pledged in 2015 that all research conducted on the agency’s premises would adhere to federal manufacturing standards. (Tom Williams/CQ Roll Call File Photo)

A key contractor at the National Institutes of Health is urging employees to forgo compliance with federal guidelines, citing consent agreements signed by patients that acknowledge the risk of participating in clinical research at the agency, Roll Call has learned.

The agency denies the contractor’s actions and that it would ever relax compliance.

Draft Drug Price Order Focuses on Regulations, Trade
Administration seeks faster drug approvals, promoting drug competition

The Trump administration is readying an executive order on drug regulations. (Scott Olson/Getty Images)

BY ANDREW SIDDONS AND JOE WILLIAMS

The Trump administration might seek to roll back regulations in pursuit of faster drug approvals, promoting drug competition and new payment models for federal health insurance programs, according to a draft executive order obtained by CQ Roll Call.

NIH Probe by House Panel Expands
Energy and Commerce asks for documents related to 2015 scandal

Francis S. Collins, director of the National Institutes of Health, is under fire from House Republicans, upset over a scandal at the agency, as well as Collins’ views on research issues. (Tom Williams/CQ Roll Call File Photo)

The National Institutes of Health is in hot water again with the House Energy and Commerce Committee over a scandal that occurred nearly two years ago at one of the agency’s main research institutions.

On Thursday, the panel broadened its probe into safety and compliance issues at the NIH Clinical Center, a research hospital located on the agency’s campus in Bethesda, Maryland. In a letter sent to Director Francis Collins and obtained by Roll Call, the committee requested a larger swath of documents not yet provided by the agency.

Policymakers Face Pressure to Act on Drug Pricing
Some proposals appear likely to gain traction

Indiana Sen. Todd Young leaves a Senate Republican policy lunch in the Capitol in February. (Bill Clark/CQ Roll Call file photo)

A proposal that would open the door for the import of low-cost prescription drugs from Canada was defeated at a Senate markup Thursday, but the proposal is unlikely to be gone for good. Lawmakers from both parties seem to want to demonstrate concern about drug prices to voters.

The administration also appears interested in addressing the issue, with Health and Human Services Secretary Tom Price holding listening sessions with patient groups and think tanks in recent weeks.

Post-Comey Senate Forecast Is Turbulent
Procedural roadblocks could set back legislative ambitions

Aides to Senate Minority Leader Charles E. Schumer declined to comment on what steps Democrats planned to take should none of their demands on the Russia probe be met. (Bill Clark/CQ Roll Call)

BY JOE WILLIAMS AND NIELS LESNIEWSKI

A partisan standoff in the fallout of the firing of FBI Director James B. Comey could significantly stall the Senate legislative calendar, as Democrats appear ready to utilize procedural rules to coerce Republicans into acting on a number of demands.

Crucial Health Bills Have a Fraught Path Amid Partisan Blowups
Bickering could delay progress on changes to 2010 health care law

Oregon Sen. Ron Wyden, the ranking Democrat on the Senate Finance Committee, said the panel will next focus on Medicare policies related to patients with chronic illnesses. (Tom Williams/CQ Roll Call file photo)

A highly anticipated markup of a must-pass Food and Drug Administration bill was postponed Wednesday because of partisan sparring over the firing of FBI Director James B. Comey. The delay comes after the Senate Finance Committee last week indefinitely postponed a hearing on the Children’s Health Insurance Program because of the toxic politics of the Republican health care bill. The cancellations raise questions about whether a deluge of drama consuming the Capitol could push lower-profile but important health care legislation off the rails.

Both bills — which congressional leaders hoped to pass without major controversies — need to be addressed well before their Sept. 30 deadlines so the FDA employees and children’s health providers who rely on funding affected by the bills can keep working.

An Early Preview of Democrats’ Health Care Strategy
Amendments on health law possible at unrelated markup

Sen. Christopher S. Murphy, D-Conn. (Bill Clark/CQ Roll Call File Photo)

One Senate Democrat is looking to quickly ratchet up pressure on Republicans in the chamber who are now crafting their own legislation to repeal large portions of the 2010 health law.

Opinion: Stifling Competition Reduces Access to Affordable Prescriptions
FAST Generics Act easy way to lower costs for patients and taxpayers

Martin Shkreli, former CEO Turing Pharmaceuticals, invoked his Fifth Amendment right against self-incrimination during a House Oversight and Government Reform Committee hearing on "methods and reasoning behind recent drug price increases," in February 2016. Turing had raised the price of a drug used by AIDS and cancer patients  from $13.50 to $750 a pill. (Tom Williams/CQ Roll Call File Photo)

“We don’t want excessive profiteering. But the key word in profiteering is profit.”

When Martin Shkreli told Business Insider this in 2015 he might not have been trying to make a broad statement about perverse incentives in the regulatory status quo. But the statement did belie real problems that arise from a system far more complex than the heroes and villains of many popular media narratives.