FDA

Opinion: One Year Later — Why 21st Century Cures Still Matters
Help underway for diseases that impact virtually every family

Rep. Fred Upton, R-Mich., left, and Rep. Diana DeGette, D-Colo., hold thank you signs made by Max Schill, who’s diagnosed with Noonan Syndrome, a rare genetic condition, after the U.S. House of Representatives voted in favor of the 21st Century Cures Act on Capitol Hill in Washington in 2015. Upton and DeGette spearheaded the act. (Al Drago/CQ Roll Call file photo)

 

 

Trump Declares Opioid Crisis a ‘National Health Emergency’
“We can be the generation that ends the opioid epidemic,” president says

President Donald Trump said addressing the opioids crisis “will require all of our effort.” (Chip Somodevilla/Getty Images)

Updated 5:30 p.m. | President Donald Trump on Thursday declared the nations’s opioid crisis a “national health emergency,” saying the country would fight the drug epidemic as a “national family.”

“This is a worldwide problem,” he said, flanked by public health officials, families with small children and first lady Melania Trump in the East Room of the White House. “It’s just been so long in making. Addressing it will require all of our effort.”

Trump to Declare Opioid Crisis a Nationwide Public Health Emergency
Officials say administration working with Congress on additional funding

President Donald Trump’s declaration will make the opioid crisis the number one priority for federal agencies, senior administration officials said. (Chip Somodevilla/Getty Images file photo)

President Donald Trump will declare the opioid crisis a nationwide public health emergency on Thursday, according to senior administration officials.

The declaration would direct all federal agencies to make the crisis their number one priority. It would include awareness and prevention programs and allow the federal government to work with states to redistribute already-available grants that support substance abuse efforts.

House Begins Work on Over-the-Counter Drug Fees
FDA director: Consumers unprotected and manufacturers open to liability

(U.S. Air Force photo/ Airman 1st Class Scott Jackson)

The House began public deliberations Wednesday on a bill that would boost the Food and Drug Administration’s oversight of over-the-counter drugs in exchange for industry-paid fees.

A bipartisan draft bill released earlier this week has support from the FDA and the over-the-counter drug industry. Under the new proposal, drug manufacturers would pay an annual fee for their facilities and an extra fee each time they submit a request to review proposed changes related to their product.

‘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.