Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry
On October 27, 2023, the Ninth Circuit Court of Appeals, in Aggarwal v. DEA, held that the U.S. Drug Enforcement Agency (DEA) must reconsider its denial of a petition to transfer psilocybin, the active ingredient in “magic...more
In what could be a groundbreaking case for psychedelic medicine, VS counsel Shane Pennington is part of a team working on an exciting and very important Ninth Circuit challenge to the U.S. Drug Enforcement Administration’s...more
This week in Washington: Congress remains in a district work period, while COVID-19 legislative talks continue....more
On 23 July, the U.S. Food and Drug Administration (FDA) announced a new proposed rule that would require sponsors and manufacturers who provide an ‘‘eligible investigational drug’’ under the Right to Try Act to submit an...more
This week in Washington: House passes first set of Appropriations bills; President Trump signs Executive Orders on Prescription Drugs after COVID-19 bill stalled....more
On July 23, the U.S. Food and Drug Administration (FDA) announced a new proposed rule that would require sponsors and manufacturers who provide an ‘‘eligible investigational drug’’ under the Right to Try Act to submit an...more
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more
Out of a sample of 29 non-representative drug manufacturers surveyed earlier this year, 23 had publicly posted policies related to accessing their investigational drugs outside of the context of formal clinical trials,...more
In the U.S., patient access to investigational cancer drugs—outside of clinical trials licensed by the U.S. Food and Drug Administration (FDA)—has historically proven insurmountable for most patients for at least the...more
Over the last few months, FDA has continued its efforts to encourage and facilitate the use of the agency’s Expanded Access Program (EAP). This follows other FDA EAP actions, including its announcement of program...more
On May 30, President Trump signed the Right to Try Act. The Act authorizes the use of experimental drugs without pre-approval or oversight by the Food and Drug Administration. Both the patient and the drug must meet certain...more
Often those with terminal illnesses wish to try new experimental therapies. Now they can if they are willing to accept the risks. On May 30, 2018, President Trump signed into law the Right to Try Act. The Act allows eligible...more
How Federal Preemption (or Lack Thereof) Could Influence the Use of Federal "Right to Try" - As discussed in our Alert of June 4, "Right to Try" Comes to the Federal Stage: What Stakeholders Should Do Now, manufacturers,...more
Recently, President Donald Trump signed into law the Right to Try Act of 2018 (RTTA).1 The RTTA represents the federal version of laws previously passed by a majority of the states, but with important differences. This WSGR...more
On May 30, 2018, President Trump signed the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2018. The bill allows the provision of certain unapproved, investigational drugs to patients...more
This client alert provides background on two recent developments related to patient access to investigational therapies outside of the clinical trial setting: expanded access and right-to-try. First, we discuss a fairly new...more
On May 30, 2018, surrounded by patients directly impacted by tragic and intractable diseases, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017...more
Outlook for This Week in the Nation's Capital - Minibus Appropriations Strategy. The House and Senate are planning to move appropriations bills in small packages of two or three bills in order to avoid a significantly delayed...more
The federal bill was signed into law on May 30 by the president, and will present new opportunities and challenges to clinical trial sponsors and healthcare entities....more
Outlook for This Week in the Nation's Capital - Recess Week. Both the House and Senate are in recess this week. Opioid Legislation. Majority Leader McCarthy has said that the House is planning to consider its expansive...more
The U.S. House of Representatives (House) is slated to vote today on S. 204, a ‘Right to Try’ bill passed by the Senate in August 2017. House Majority Leader Kevin McCarthy announced last week that the House vote was...more
Foreign policy – particularly trade with China and the standoffs with Iran and North Korea – is likely to compete for attention this week among policymakers in the Trump administration and on Capitol Hill....more
RYAN SAYS POTENTIAL COMPROMISE COMING ON RISK EVALUATION AND MITIGATION STRATEGY DRUGS - House Speaker Paul Ryan, R-Wis., last week said congressional leaders are trying to hammer out compromise legislation that would make it...more
"Right to Try" legislation, which enables terminally ill patients or patients with a "life threatening disease or condition" to seek access to investigative drugs with little to no oversight from the FDA, has been enacted in...more
CONGRESS RECONVENES, WITH A FOCUS ON OPIOIDS - Lawmakers return today to Capitol Hill after a two-week recess, and multiple committees in both the House and Senate are poised to examine the opioid crisis and potential...more