On September 10, 2018, the federal Food & Drug Administration (”FDA”) released its revised draft standard Memorandum of Understanding (“MOU”) between states and the FDA addressing the interstate distribution of compounded drug products. See 83 Fed. Reg. 175, 45631 et seq. (Sept. 10, 2018). The draft is the latest in the FDA’s decades-long effort to clarify state and federal roles in investigating and responding to complaints related to compounded drug products shipped between states. Continue Reading FDA publishes revised draft MOU addressing state and federal oversight of 503A compounding pharmacies
The Orphan Drug Act aims to incentivize treatment of rare disorders or conditions affecting fewer than 200,000 persons in the United States through: (1) federal funding of grants and contracts to perform clinical trials of orphan products; (2) a tax credit of 50 percent of clinical testing costs; and (3) an exclusive right to market the orphan drug for approved orphan indications for 7 years from the date of marketing approval. While these financial incentives certainly make the business decision to engage in orphan drug development more palatable, the FDA does not approve orphan drugs on a separate pathway, despite the limited understanding of the diseases in question that presents developers of these drugs with problems stemming from small sample size and lack of well-defined efficacy endpoints. Continue Reading FDA guidance may improve pediatric orphan drug success
The U.S. Food and Drug Administration (“FDA”) panel’s unanimous recommendation to approve Sandoz’ application for a filgrastim biosimilar of Amgen’s Neupogen® on Jan. 7, 2015, brings into sharp focus the provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) for resolving patent issues. The imminent approval by the FDA of Sandoz’ application now leaves resolution of patent issues for Sandoz to contend with as it prepares to launch its biosimilar filgrastim product. The lawsuit to resolve these issues, however, has just begun. Continue Reading Patent issues will remain after FDA approval of Sandoz’ application for filgrastim
The world of animal health is constantly changing, and animal health companies must stay on top of regulatory changes to have a successful license. Michael Annis and I recently presented on what an animal health company needs to manage when considering an in-license or an out-license and the regulatory impact on a licensing strategy. In our presentation, we considered these questions:
- Are you positioned correctly for a licensing deal? Do you understanding how the regulatory landscape will impact a license?
- What are key licensing terms and the implications of those terms?
- What are the negotiation pitfalls to be aware of? How do you avoid them when negotiating a license?
Licenses can be valuable tools for animal health companies to move assets to market. However, there are many considerations when entering a license, and the focus should generally be on the long-term partnership. Further, these agreements are difficult to negotiate and the smaller company often gets “out gunned” by the bigger player. Companies should use their resources to avoid these situations.
On April 16, in a win for Purdue Pharma, the maker of OxyContin, the FDA issued a decision approving updated labeling for Purdue’s reformulated, abuse-resistant OxyContin tablets. The decision places drug makers on notice that the FDA will not accept or approve any abbreviated new drug applications (generics) that rely upon the agency’s December 1995 approval of Purdue’s original OxyContin formulation.
The FDA’s decision was issued just as Purdue was set to lose its patent on the original formulation of OxyContin. Loss of this patent would have opened the opioid-painkiller market to competition from generic drug makers. But now, going forward, new applications for generic “copycat” forms of the drug must meet Purdue’s approved, abuse-resistant standard, without infringing upon Purdue’s patent for reformulated OxyContin, which lasts until 2025.
Concern over abuse of the well-known painkiller was central to the FDA’s decision. The agency explained, in a press release accompanying its decision: Purdue’s “labeling indicates that the [reformulated] product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting).” The press release further stated that: The original formulation of OxyContin “was abused, often following manipulation intended to defeat its extended-release properties. Such manipulation causes the drug to be released more rapidly, which increases the risk of serious adverse events, including overdose and death.”
According to the New York Times, the FDA’s decision was pushed by some state attorneys general, as well as pain treatment experts, who argued that the release of generic versions of OxyContin would feed street demand for the narcotic. Critics, however, have argued that the decision will result in higher prices for OxyContin, as the reformulated drug will not face generic competition. Continue Reading FDA Bars Generic “Copycat” OxyContin: Will Efforts to Limit Abuse of the Painkiller Also Limit Competition?
Cyber security is on everyone’s mind. President Obama signed an executive order in February aimed at increasing protection of our nation’s critical infrastructure, while HHS released its new HIPAA mega rule in January (effective in March) in an effort to strengthen the security of electronic health records. As providers work to update their HIPAA policies and procedures, there’s another area of concern to consider: the hacking of implantable medical devices.
In August of last year, the Government Accountability Office, the “congressional watchdog,” released a report identifying information security issues associated with medical devices and advising the FDA to ramp-up its efforts to address these issues. These devices include implantable defibrillators, insulin pumps, pacemakers, and other devices used to monitor and transmit a patient’s medical status. Specifically, the GAO considered intentional threats to such devices, including hackers obtaining unauthorized access, or using malware, viruses, or worms to interfere with the functioning of the device. Although there have been no documented incidents thus far, the GAO cited several demonstrations in controlled settings showing that hacking of these devices is a real threat. In one demonstration, the researchers were able to remotely deliver commands to a defibrillator. Other demonstrations revealed that hackers could prevent insulin pumps from operating properly or manipulate the amount of insulin to be dispensed.
Unfortunately, the GAO report also acknowledged that efforts to address the security issues associated with these devices could adversely affect the performance of the devices. For one, pacemakers cannot be made immune to all electrical signals because the device must be able to detect the signals naturally generated by the patient’s heart to determine irregularity in pulse. Further, adding encryption – a security feature of which most providers are aware – could drain a device’s battery, which can only be replaced by surgery.
Our Insight. Your Advantage. The FDA has stated that, in the future, the agency will consider information security risks resulting from intentional threats when reviewing new devices submitted by manufacturers. The FDA officials also stated that they were currently planning to review its approach to evaluating software used in medical devices. In the meantime, the GAO has recommended the commissioner of the FDA develop a comprehensive plan to address this issue, including increased focus on manufacturer identification of security issues.
While there may be security issues associated with implantable medical devices, the benefits of these devices should not be forgotten. However, it is frightening to imagine a scenario where the security issues identified in the GAO report are realized. Hopefully such events are confined only to movie screens.
To read the full GAO report, click here.