We are pleased to welcome attorney Katlin McKelvie Backfield to our nationally recognized Health Care Group. Katlin comes to Verrill Dana with more than 15 years of pharmaceutical regulatory experience, including more than a decade at the Food and Drug Administration. (more…)
Posts Tagged: FDA
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, patients, providers and IRBs are now grappling with two alternative federal pathways through which manufacturers may (but are not required) to provide investigational drugs for treatment purposes outside of an FDA-overseen clinical investigation. As manufacturers, treating physicians, institutions, and other stakeholders pause to consider whether to accommodate or facilitate access through the federal “right to try” law, we explore some of the factors that may influence this decision. In particular, this Alert examines the continuing force of the forty (40) enacted state “right to try” laws in relation to the new federal “right to try” law. Ironically, manufacturers seeking to avoid patchwork regulation may conclude that federal “right to try” could increase, rather than decrease, the number of requirements they need to address when voluntarily providing access. (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 (S. 204), which had passed the Senate on August 3, 2017 and then the House of Representatives on May 22, 2018 (following an unsuccessful attempt by the House to get an alternative bill, H.R. 5247, passed by the Senate this spring). The enacted federal “right to try” law follows the passage in 40 states thus far of similar state laws, a process put into motion by the Goldwater Institute, a libertarian organization in Arizona that developed the model “right to try” legislation on which most of the state laws are based.
On its face – and in the associated rhetoric – the federal “right to try” law provides a pathway through which patients may seek access to certain investigational drugs without FDA approval and also without IRB oversight. Proponents have argued that removing these oversight barriers will improve the speed with which seriously ill patients can access investigational products, while opponents have criticized “right to try” laws as offering patients false hope and increasing risks to patients. The impact of the federal law on stakeholders’ behavior remains to be seen. (more…)
Whether or not you agree with its position, there is no denying that in its recently released report, “Dead on Arrival,” the Goldwater Institute takes a passionate stance on the current status of the federal “Compassionate Use” program and its counterpart, the increasingly vigorous state-led initiative known as the “Right to Try” movement, a statutory phenomenon initially ignited by the Goldwater Institute, a private think-tank.
“Compassionate Use”, formally referred to as “Expanded Access”, is a process by which terminally ill patients can petition the Food and Drug Administration (“FDA”) and drug manufacturers for access to investigational drugs that have not yet been approved by the FDA. The process for accessing these investigational drugs has been criticized as time consuming and arduous. In addition to meeting a litany of eligibility criteria, applicants must find a physician who is willing to submit an application on their behalf, convince the drug manufacturer to provide the sought after treatment, and obtain approval from the FDA. Even if the FDA approves an applicant’s Expanded Access request, it cannot require a reluctant drug manufacturer to provide access to its investigational drugs. In response to these criticisms, the FDA has recently revised the Expanded Access application form to streamline the process and has reported data which show an extremely high approval rate by the FDA for Expanded Access requests.
Pulling no punches, the Goldwater Institute unequivocally states that the current Expanded Access program is challenging by design. The bulk of the Goldwater Institute’s criticism falls on the process the FDA uses to approve new drugs to market generally, outside of the Expanded Access pathway. The only way to receive approval to market a drug is through clinical trials, for which the FDA utilizes an “all or nothing” approval approach. In other words, if the clinical trial fails at any level, the drug will never hit the market. This encourages drug manufactures to be extremely risk averse and creates disincentives for companies to make investigational products available to patients in need. Companies don’t want to take any chances providing a drug through Expanded Access, lest a reportable adverse event (like death) experienced by a “risky” patient off-protocol bring the on-going trial to a halt. (more…)