Food and Drug Administration (FDA)

Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of July 24, 2017.  This week’s preview focuses on the Better Care Reconciliation Act and Senate parliamentary rules.  The preview also addresses Wednesday’s House Energy & Commerce Health Subcommittee’s hearing on Special Needs Plans, FDA User Fee Reauthorizations, and the health care minibus.

Stay tuned for additional updates from ML Strategies!

Our colleagues at ML Strategies have provided a Health Care Weekly Preview.  This week’s preview describes the Better Care Reconciliation Act (BCRA), the User Fee Acts (UFAs), the National Defense Authorization Act (NDAA), and the health care Minibus.

Stay tuned for additional updates and analysis from ML Strategies.

Facing pressure from stakeholders and technological realities, the U.S. Food and Drug Administration has again delayed its enforcement of parts of 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, with phased-in obligations for the various trading partners over 10 years, beginning with the law’s passage in November 2013. Covered trading partners include manufacturers, repackagers, wholesale distributors, and dispensers, whose upcoming compliance obligations under the DSCSA are all addressed by FDA in the recently issued Compliance Policy guidance documentContinue Reading FDA Delays Enforcement of Prescription Drug Product Identifier and Related Requirements

Our colleagues at ML Strategies have provided a Health Care Weekly Preview.  This week’s preview describes the ongoing wrangling in the Senate over health care reform as well as highlighting the upcoming need to address FDA User Fees and the health care minibus

Stay tuned for additional updates and analysis from ML Strategies.

It appears that – at least for now – the U.S. Food and Drug Administration (FDA) is serving as the public face of the executive branch’s efforts to tackle the increasingly contentious debate about prescription drug prices. As we previously reported, following a May 25, 2017 budget hearing, FDA Commissioner Scott Gottlieb has made increased competition in the drug marketplace a high policy priority for the Agency. To that end, we have recently seen concrete steps being taken to advance Dr. Gottlieb’s multi-pronged “Drug Competition Action Plan.” Continue Reading FDA Stays in the Spotlight with Drug Pricing Moves, but Could Be Facing Risk as UFA Bill Loses Attention

This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue describing how FDA’s regulatory scheme has persisted in light of the key First Amendment decisions involving off-label promotion. Even though FDA hesitated in and ultimately rejected promulgating regulations that would make any action “that directly or indirectly suggests to the physician or to the patient that an approved drug may properly be used for unapproved uses for which it is neither labeled nor advertised” (37 Fed. Reg. 16,503, 16,504) into a matter warranting enforcement action, the Agency used this reasoning to shape an off-label communication policy. As I described in Part 2, FDA’s policy enjoyed some support from federal courts; however, this support was only temporary. More recently, federal courts have shown support for the idea that truthful and non-misleading promotions of off-label uses of drugs and devices by manufacturers are protected under the First Amendment. A review of the pivotal cases in this area will help put FDA’s off-label policy in perspective, especially in light of FDA’s reaction to these cases in a memorandum published in January 2017. Continue Reading The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 3

On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral arguments on the last day of the Court’s October 2016 Term, as we previously reported. With respect to both of the significant issues presented, the Justices unanimously reversed the Federal Circuit Court of Appeals split opinion and remanded for further consideration of questions related to State law.

Although our intellectual property colleagues have separately analyzed the “Patent Dance” implications of the Court’s decision in Amgen v. Sandoz (see here), the second issue presented in the case related to the proper interpretation of the 180-day notice provision of the Biologics Price Competition and Innovation Act (“BPCIA”). The Federal Circuit had held that such notice by the biosimilar applicant can only be provided to the reference product sponsor after FDA licenses (i.e., approves) the biosimilar application.  Continue Reading SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs

Congress returns from its Memorial Day recess to four full weeks of legislative activity. The drama of the American Health Care Act (AHCA) now hangs over the Senate. The House will return to its regular work once they advance the FDA User Fee Reauthorization, with the Senate also having to schedule floor time for the package. Also on our radar this month will be the date June 21st– the date in which insurers decide if they will participate in the Obamacare Marketplace for 2018. This could play a role in the Administration’s ongoing discussions regarding cost-sharing reductions, as well as how the Senate approaches its version of the AHCA. Continue Reading Congress Returns for June Session to Face AHCA, User Fees and More

During his first appearance before Congress as FDA Commissioner on May 25, 2017, Scott Gottlieb reported that the Agency is preparing a “Drug Competition Action Plan” that it will unveil in upcoming weeks and months. This was likely welcome news to many politicians from both parties, as well as to President Trump, who has publicly shamed pharmaceutical companies for the high prices of their products but has done little to advance concrete policies in this area.

Dr. Gottlieb has been consistent over the years, including during his recent confirmation process, in his view that FDA should take a more active role in fostering competition and reducing unnecessary regulatory barriers. So it was not surprising when he was selected by Trump to lead the Agency, nor when he received a relatively warm welcome from Senators concerned about the direction prices have been going in recent years. Continue Reading FDA Commissioner Hints at Drug Pricing-Related Initiatives

On May 23, the White House released its 2018 budget proposal, outlining its priorities for the upcoming fiscal year. In health care, the President has proposed cuts to several agencies and programs. The Administration’s annual budget is seen as a statement of policy, not necessarily a legislative proposal certain to become law. That said, ML Strategies has summarized the highlights from the Health and Human Services Budget that are worth monitoring as Congress begins its work on the FY 2018 budget.  The summary is available here. ML Strategies will continue its coverage here of ongoing health care issues on Capitol Hill that will need to be addressed later this year, such as the FY18 budget and the Health Care Minibus.