Life Sciences

This week, Congress and the White House need to finalize a government spending bill in order to avoid a shutdown. While all signs point to a deal being reached, it is widely expected that several agencies will be operating on a continuing resolution for the first couple months of fiscal year 2019. While the Departments of Labor, HHS, and Education are expected to receive a full appropriation prior to September 30th, the FDA, which is funded through the Department of Agriculture, is expected to be funded through the continuing resolution, which will go through December 7th.

As an immediate follow-up to last week’s release of the FDA’s Biosimilars Action Plan, the Agency is announcing a public hearing for September 4, 2018 to gather stakeholder input on “FDA’s approach to enhancing competition and innovation in the biological products marketplace, including by facilitating greater availability of biosimilar and interchangeable products.”

In May, the Trump Administration announced its Blueprint to Lower Drug Prices and HHS Secretary Azar issued a Request for Information seeking comments from interested parties “to help shape future policy development and agency action” related to drug pricing issues.

In the time since the Federal Circuit issued its Vanda Pharma decision in April, Vanda Pharm. Inc. v West-Ward Pharm. Intl. Ltd. 887 F.3d 1117 (Fed. Cir. 2018), we have had more good news for the patent eligibility of claims relating to diagnostic or similar tests utilized in treating patients.

In a highly anticipated step, which had been teased by agency leadership in their public appearances over the past several months, FDA released a series of draft guidance documents pertaining to the development and approval of gene therapy products on July 11, 2018.

Recently the U.S. Department of Justice (DOJ) issued a statement that it had intervened in a False Claims Act (FCA) case against Insys Therapeutics, Inc. and consolidated five separate qui tam cases into one case, U.S. ex rel Guzman v. Insys Therapeutics, Inc., filed in the U.S. District Court for the Central District of California.

On Wednesday May 9th, I was floored when the Administration released the Spring 2018 Unified Agenda of Regulatory and Deregulatory Actions, which contained this nugget: by December 2018, HRSA will publish its 340B Omnibus Guidance. Readers of our blog know that, as we predicted, this so-called Mega-Guidance was withdrawn in January 2017 without ever seeing the light of day.

On Friday, after weeks of delay, the President finally delivered his Drug Pricing Speech and released the HHS Blueprint detailing the Trump Administration's plan to lower drug prices and reduce out-of-pocket costs.

On Tuesday, May 8th, the House held three hearings related to combating the opioid epidemic. The first hearing came out of the Energy and Commerce (E&C) Subcommittee on Oversight and Investigations, which examined opioid distribution and diversion by the pharmaceutical industry.

The Federal Circuit’s decision in Vanda Pharm. Inc. v West-Ward Pharm. Intl. Ltd. (2016-2707, 2016-2708 April 13, 2018) provided some good news on the subject matter eligibility front for innovators and other stakeholders in the personalized medicine space, as discussed in a previous post.

On April 16, 2018 in a precedential opinion, the United States Court of Appeals for the Federal Circuit, Sumitomo Dainippon Pharma v. Emcure Pharms., Nos. 2017-1798, -1799, -1800, affirmed the United States District Court for the District of New Jersey by construing the claimed chemical structure diagram to encompass at least the specific enantiomer depicted, refusing to limit the claim to only cover a racemic mixture of the (+) and (–) enantiomers, absent clear indication that the depicted enantiomer should be excluded from the claim.

The Federal Circuit provided a welcome boost for stakeholders in the field of personalized medicine with its recent decision in Vanda Pharm. Inc. v West-Ward Pharm. Intl. Ltd. (2016-2702, 2016-2708 April 13, 2018).

Last month, the Department of Health and Human Services’ Office of Inspector General (OIG) released its latest report on compliance with the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post, the DSCSA requires enhanced security and accountability for prescription drugs throughout the U.S. pharmaceutical supply chain.

Earlier this week, CMS released both the Contract Year 2019 Final Rules for Medicare Advantage and Part D (Final Rules) and the 2019 Call Letter. CMS also released fact sheets for the Final Rule and the Call Letter.

Mintz and ML Strategies will host the 3rd Annual Pharmacy & Pharmaceutical Industry Summit on May 8, 2018! This year's summit will take place in Boston and we are thrilled to announce that Massachusetts Governor Charlie Baker will be the keynote speaker. 

Although the options for accelerated FDA pathways have recently expanded, the current political climate has increased scrutiny of expedited approvals. Next week, my colleague Bethany Hills will be moderating a panel discussion in our Boston office about the realities of pursuing an accelerated pathway.

Ken Cohen discusses how raising money for life sciences companies is different than for technology companies and gives entrepreneurs advice on how to finance and grow their life sciences company.

As we predicted in our year-end post on civil and criminal enforcement trends, 2018 is already off to strong start in opioid-related enforcement against individual providers and associated practices. 

The pharmaceutical industry is facing new limits on payments to prescribers in New Jersey. Earlier this month the state's Division of Consumer Affairs finalized sweeping new rules prohibiting some types of payments and capping others. New Jersey now joins the ranks of other states, like California and Massachusetts, with specific payment prohibitions between manufacturers and prescribers.

It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation's abbreviated marketing pathway for biosimilar products.