On April 14, 2017, Congress released a discussion draft of a bill to reauthorize the FDA’s various user fee programs, commonly referred to as “the UFAs.” The FDA Reauthorization Act (FDARA) would renew the Agency’s authority to collect user fees in Fiscal Years 2018 through …
We last updated readers on the Decosters’ criminal case in January, when the Decosters timely petitioned the Supreme Court for review of the Eighth Circuit decision upholding their three-month prison sentences under the FDC Act. Last week, the government responded to that petition. As reported in …
FDA generated a great deal of the buzz a few weeks ago when it proposed exempting more than 1,000 Class II devices from the 510(k) requirements (see our earlier post here). Given the excitement, we thought it might be worth discussing what devices are no …
As we reported previously, just before President Trump took the oath of office, FDA issued two guidance documents regarding its approach to the regulation of genetically engineered (“GE”) animals. One of those guidance documents was a revision of a 2009 guidance document that, for the first …
Since the Supreme Court’s decision in United Health Services v. United States ex rel. Escobar, we have seen a narrowing of situations in which courts will find liability under the False Claims Act (“FCA”). A district court in Pennsylvania provided yet another example of this …
Over the years, there have been a number of DEA administrative actions against physicians based on a recurrent theme of trading sex for drugs. Also, every prosecutor knows that these themes of sex, drugs, and rock and roll make for a lively case before a …
Without pomp or circumstance, Congressman Morgan Griffith (R-VA) introduced a bill on March 27, 2017, that would expand the communications pharmaceutical and medical device companies can have with doctors about their products. The bill, titled the Medical Product Communications Act of 2017, seeks to clarify …
In the rhythm of life, timing is everything! It was just last week when we posted on an interesting issue arising as a result of the intersection of exclusivity and off-label promotion. We suggested that some controversy might arise as a result of some decisions …
The intersection of exclusivity and off-label promotion issues is not common, but quite an interesting issue nevertheless. A recent press release from Egalet Corporation (“Egalet”) raises the possibility that FDA may be challenged – perhaps in court – as a result of the Agency’s decision …
On March 29, 2017, Senator Al Franken (D-MN) and several other Senate Democrats introduced S. 771, the “Improving Access to Affordable Prescription Drugs Act.” A companion bill, H.R. 1776, was introduced in the House on the same day by Representatives Jan Schakowsky (D-IL), Elijah Cummings …
On March 22, 2017, the jury rendered its verdict in the case of the United States v. Cadden, in the U.S. District Court for the District of Massachusetts (jury verdict form available here). The defendant, Barry J. Cadden, was the part owner and head pharmacist at …
On March 23, 2017, DEA issued an Interim final rule “placing FDA-approved products of oral solutions containing dronabinol in schedule II of the CSA.” Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral solutions Containing Dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] in Schedule II, 82 Fed. Reg. …
Not long ago, we recommended that the Food and Drug Administration (FDA) begin a new rulemaking to update the intended use regulation. We promised a blog post to get the ball rolling with suggestions for improvement. The time has arrived. In the discussion below, the first …
The Interagency Food Safety Analytics Collaboration (IFSAC) has issued a strategic plan for the 5-year period beginning in 2017. This is the second such plan issued by IFSAC, a collaboration between FDA, USDA/FSIS, and CDC that aims “to improve coordination of federal food safety analytic efforts …
The American Conference Institute’s (“ACI’s”) 11th annual “Paragraph IV Disputes” conference is right around the corner! The conference will take place from April 24-26, 2017 at the Conrad New York in New York, NY. ACI has put together an excellent program for conference attendees that includes presentations from esteemed …
