Recent Blog Posts
- The Scope of FDA’s Proposed Revisions to the IND Regulations May Not Be Sufficient to Achieve Its Stated Goals Last week, the U.S. Department of Health and Human Services (“HHS”) announced that FDA intends to update its regulations governing clinical studies of new drugs. More specifically, FDA intends to update Parts 312 and 16 of Title 21 of the Code of Federal Regulations (the “Code” or “CFR”). In its announcement, HHS stated that the revisions will be focused on defining and clarifying “the roles and responsibilities of the various persons engaged in the initiation, conduct, and oversight of clinical... More
- Will Sad Facts Make Bad Law? Despite popular opinion, lawyers and judges are human and sometimes the facts of a case make it near impossible for judges to play the role of the modest umpire calling balls and strikes described by Chief Justice Roberts in his confirmation hearing. Sometimes, bad facts make bad law because the plaintiff is so sympathetic that the just ruling may not be the “right” one. Fachon v. U.S. Food and Drug Administration et al., appears to be the epitome of this.
- Are Lower Cost Drugs Less Effective? It May Depend on the Patient’s Perspective. One of the most discussed aspects of healthcare has to be how to balance cost, quality and access. This is especially true when it comes to the pharmaceutical industry, particularly with the rapid growth of and increased focus on highly effective, but highly expensive, specialty drugs. Discussions about these costs are no longer isolated to negotiations between pharmaceutical companies, PBMs and insurers; instead it appears that price and cost are on FDA’s radar.
For example, the Oncologic Drugs Advisory Committee... More
- ‘Tis the Season of Giving: FDA Grants an Informal Extension for Product Tracing Compliance Earlier today, FDA published guidance, for immediate implementation, effectively delaying the effective date of the product tracing requirements for manufacturers, wholesale distributors or repackagers until May 1, 2015. This guidance appears to be a continuation of FDA’s efforts to address industry’s concerns about the implementation of the DSCSA product tracing requirements that are effective January 1, 2015.
It is unclear whether the ghosts of FDA past, present or future had anything to do with today’s announcement, but this Dickens-esque change of... More
- FDA’s Wholesale Distributor and 3PL Reporting Requirements Draft Guidance Provides Some Clarity Not Found in Previous Draft Guidance FDA is the subject of a lot of criticism, some deserved, and some not. However, I don’t think FDA gets enough praise when it does something right. Therefore, I thought it was important to follow up on my previous blog and let everyone know that FDA has cleared up some of the ambiguities I mentioned there.
Specifically, on December 9th, FDA issued draft guidance making it clear that federal, and not state, law determines whether a company needs to register with... More
- Five Issues to Consider While Reviewing the Clinical Trial Registration Proposed Rule
Earlier this week the Department of Health and Human Services (“HHS”) published its long awaited notice of proposed rulemaking regarding the registration of clinical trials. The most significant change that would result from implementation of the proposed rule, and the one getting the most press, is the new requirement that results data be submitted for all applicable clinical trials, even those evaluating unapproved drugs and devices. Although we agree that this new requirement is likely to have significant ramifications for... More
- FDA’s Second Guidance on the Drug Supply Chain Security Act Misses the Mark
Although FDA appropriately identified the need for guidance on the Effect of Section 585 of the FD&C Act on Drug Product Tracing, Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements; the Draft Guidance issued by FDA this month does not ask the right questions.
In November 2013, Congress enacted the Drug Supply Chain Security Act (“DSCSA”) with the intent of establishing a “Uniform National Policy” for wholesale distributor and third party logistics provider (“3PL”) licensure. Congress hoped to... More
- Three Takeaways from the Advances in Clinical Technology Conference About a month ago, I had the opportunity to participate at the Inaugural Advances in Clinical Technology conference in London. The conference covered a broad array of topics relating to how technology can and is changing how clinical trials are conducted. Here are the top three things that I took away from the conference.
1. The upsides of the e-patient far outweigh the downsides
Earlier this year, the Wall Street Journal published an article highlighting one of the biggest downsides of the... More
- FDA Jurisdictional Determinations Should Not Be a Riddle, Wrapped in a Mystery, Inside an Enigma Upon learning that FDA had lost another round in its battle to classify Diphoterine® Skin Wash (DSW) as a combination product with a drug primary mode of action and that Prevor, DSW’s manufacturer, was still fighting this issue nearly six years after it submitted its initial premarket notification for DSW, I turned into a five-year-old and kept asking why?
Why does FDA insists that a skin wash intended to “help prevent and minimize accidental chemical burn injuries” must be regulated as... More