As Prescribed

Substantial evidence, the evidentiary standard for effectiveness established in 1962 by the US Federal Food, Drug, and Cosmetic Act (FD&C Act), is the measure against which all drugs and biologics are approved in the United States. This standard is, in large part, what makes the FDA’s approval standard often considered the worldwide “gold standard” for drug approvals. Now, recent draft guidance issued by FDA looks to refine this standard even further.

FDA’s Center for Biologics Evaluation and Research (CBER), the locus of regulating cell and gene therapies among other expanding areas of biotech, is poised for change on a number of important fronts—leadership, significant growth, and plans to address challenging scientific and regulatory issues. With a well-earned reputation of stability, and slow, plodding progress, moments with so many elements in flux at FDA don’t come around often, so it is worth keeping an eye on how these begin to unfold to have a sense of where CBER—central to many of the exciting developments in industry—is headed.

The Federal Trade Commission (FTC), supported by the Food and Drug Administration (FDA), issued a policy statement on September 14 indicating that the FTC intends to “scrutinize improper Orange Book listings” to identify potential violations of Section 5 of the FTC Act, which prohibits, among other things, unfair methods of competition.

For our third and final Biotech Week Boston post, partner Stephen Altieri—one of the many within our 250-member-strong comprehensive cross-practice life sciences team with an advanced scientific degree—discusses efficient patent protection for emerging biotech companies with patent agent Emily Coury.

Fundraising is one of the key activities in the lifecycle of an emerging company: many CEOs of emerging companies have stated that they are always in financing mode. Given the high cost of bringing life science products to market, raising funds is especially challenging in the biotechnology sector.

Today marks the kickoff of the Biotech Week Boston event series, and for the rest of the week our As Prescribed blog will feature posts exclusively from our Boston life sciences lawyers. Local partners Michael Barron, Laurie Burlingame, and Stephen Altieri will be blogging from the capital of the commonwealth, where they are expressly positioned to advise biotech companies at all phases of their lifecycles, as well as the entities that invest in them.

After almost a decade, the Food and Drug Administration (FDA or Agency) finalized the Informed Consent guidance document (Final Guidance). The Final Guidance finalizes the 2014 draft Informed Consent Information Sheet guidance document (Draft Guidance) and supersedes the 1998 FDA guidance document, “A Guide to Informed Consent.” FDA issued the Final Guidance as part of an ongoing effort to modernize and harmonize its human subject protection policies and regulations.

FDA recently issued draft guidance with updated recommendations for implementing the International Council for Harmonisation’s (ICH’s) guidelines on good clinical practice (GCP). The goal of the draft guidance is to modernize the design and conduct of clinical trials, making them more agile while maintaining data integrity and participant protections. FDA has initiated a public consultation period, seeking feedback on the guidance and how its recommendations should be applied to increasingly diverse trial types and data sources.

In a continuing effort to improve the quality system effectiveness of human drug manufacturing sites, FDA revised MAPP 5014.1, Understanding CDER’s Risk-Based Site Selection Model (Site Selection MAPP or the Policy).

As drug shortages are once again front-page crises news, demanding drastic action by FDA—currently with a particular focus on sterile, injectable platinum-based chemotherapy drugs—a refresher on the scope of FDA’s tools to address a drug shortage is useful.