Tag Archives: Patrick Gallagher

FDA’s New MAPP Shows the Route to Changing Ownership of Generic Drug Applications

The U.S. Food & Drug Administration (FDA) recently issued a new Manual of Policies and Procedures (MAPP), in which it explains the Office of Generic Drugs’ (OGD) policy on facilitating changes to generic drug applications and updating the Orange Book to reflect those changes.

MAPP 5242.1 makes clear that the policies, processes and procedures for changing ownership of an application differ based on whether the change is effected by a simple transfer of ownership or whether it results from a corporate merger or acquisition.

To read the full text of this Duane Morris Alert, please visit the firm website.

COVID-19 Treatment Approvals Accelerated by New FDA CTAP Program

On March 31, 2020, the U.S. Food & Drug Administration (FDA) introduced a specially designed “emergency program”—dubbed the Coronavirus Treatment Acceleration Program (CTAP)—to provide patients with faster access to new COVID-19 treatments. The CTAP allows FDA to “move new therapies to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.”

Given the rapidly increasing rate of COVID-19 confirmed cases and fatalities in the United States, efforts to streamline FDA processes may prove crucial to uncovering and delivering viable treatments.

To read the full text of this Duane Morris Alert, please visit the firm website.

Protecting the Company’s Crown Jewels: Best Practices for Growth Stage Biotechnology Companies Using Contract Vendors in Support of Basic Research Activities

By Patrick C. Gallagher, Ph.D. and Sandra G. Stoneman

Emerging growth biotechnology companies often need to rely on third-party vendors and collaborators to fuel their research and development efforts.  These vendors and collaborators may perform crucial aspects of the R&D process, such as candidate screening, assay development and validation, and lead generation. To enable this work, biotechnology companies may be required to share their “secret sauce” (or the building blocks to an eventual secret sauce), like antibodies and their targets.  The following recommendations should be taken to account when working with third parties to balance the need to advance R&D with limited internal capacity and the need to maintain confidentiality of trade secrets and other proprietary information:

  • Strong work-product language—Ensure the contract has strong invention assignment and “work-for-hire” language.  Consider calling out specific antibodies and their targets as your “background intellectual property” or your materials. 
  • Confidentiality—Confidentiality obligations in the contract for trade secrets should survive for so long as the information qualifies as a trade secret under applicable law.
  • Subcontracting—Limit the ability of the vendor or collaborator to use subcontractors.  Understand the full supply chain and work flow, and the companies involved in each step.  For example, often vendors and collaborators want the ability to assign/subcontract to affiliates.  If that affiliate not qualified, this could present regulatory and IP protection issues.  Make sure you know who will actually have access to your confidential information and proprietary biological material.
  • Material transfer—If biological material is being transferred, consider entering into a separate “material transfer agreement” because most contract service agreements may not adequately address protections around sharing of material, and each time biological material is shared there likely will be specific limitations that will be appropriate to specify for the vendor.  At a minimum, ensure the contract limits the scope and nature of what the vendor is allowed to do with the biological material.  Also ensure that the contract requires return of all physical materials (often, the return obligations only apply to confidential information), and prohibits copying or replication except to the extent necessary for the contracted work.
  • Diligence your vendor or collaborator—ask for references, visit their location, periodically exercise audit and inspection rights under the contract.

It almost goes without saying that if a company is going to outsource R&D functions, there is some inherent risk that cannot be eliminated, but a good deal of the risk can be mitigated.

U.S. Trade Rep. Implements New Section 301 Exclusions for Certain Medical Products in Wake of Coronavirus (COVID-19)

As concerns surrounding coronavirus (COVID-19) escalate, U.S. trade policy is aligning with the country’s medical needs. On March 10, 2020, the United States Trade Representative (USTR) announced new Section 301 exclusions for certain kinds of Chinese-origin medical products. Although the USTR previously levied Section 301 duties as high as 15 percent against these products, the announced exclusions exempt them from Section 301 duties until September 1, 2020. Significantly, the new exclusions are retroactive in nature so that entities can seek refunds of the Section 301 duties that they have paid on the excluded products dating back to September 1, 2019. Assuming the USTR continues prior procedures, it is expected that the importing community will be allowed to submit written comments to support extensions of the exclusions.

This round of exclusions follows previous rounds granted by the USTR, but it represents the first since the coronavirus has taken center stage for the Trump administration. Although the USTR did not identify the coronavirus or the nation’s healthcare infrastructure as a factor in deciding to grant certain exclusions, these most recent exclusions may have been influenced by the current medical emergency. Additionally, a prime consideration was whether a particular product is only available from China, among other reasons.

View the full Alert on the Duane Morris LLP website.

FDA Postpones Foreign Inspections Through April in Response to COVID-19

FDA announced on March 10, 2020, that the agency is postponing most foreign inspections through April, effective immediately. FDA will consider whether to conduct inspections outside the U.S. deemed mission-critical on a case-by-case basis.

Postponing foreign inspection will likely delay product application reviews that require facility inspections. FDA has committed to trying to mitigate any potential impact that the COVID-19 outbreak and suspension of foreign inspections may have regarding FDA action on product applications. The extent of that impact will likely depend on how soon foreign inspections can resume and the resources, including personnel, available to FDA once they resume.

View the full Alert on the Duane Morris LLP website.

FDA’s Bark May Be Worse Than Its Bite: Revised Guidance Permits Certain Compounding of Animal Drugs from Bulk Drug Substances

On November 19, 2019, the U.S. Food and Drug Administration (FDA) released revised guidance concerning the compounding of animal drugs from bulk drug substances—in particular, the circumstances under which the FDA would not plan to take enforcement action for certain violations of the Federal Food, Drug, and Cosmetic Act (FDCA) when pharmacists and veterinarians compound or oversee the compounding of animal drugs from bulk drug substances. The guidance is intended to replace a withdrawn draft guidance concerning the compounding of animal drugs initially released in May 2015.

View the full Alert on the Duane Morris LLP website.

In a Regulatory “One-Two,” FDA Modifies Terms of Oversight Concerning Homeopathic Drugs

Late last week, the FDA—in denying a citizen petition and issuing two Federal Register notices—modified published guidance on the manufacture and distribution of homeopathic drugs and declined to convert a current policy guide (CPG) provision into an official regulation. Importantly, the FDA cautioned industry participants and consumers alike that its CPG withdrawal “does not represent a change in the legal obligations that apply to homeopathic drugs”; rather, the CPG—issued in 1988—merely no longer reflects the “current thinking” of the FDA, as it is inconsistent with the agency’s “risk-based approach to enforcement generally.”

View the full Alert on the Duane Morris LLP website.

Federal Agencies Issue Draft Guidance for Drug Master Files for First Time in 30 Years

For the first time since September 1989, federal agencies have issued draft guidance concerning drug master files (DMFs), submissions to the FDA that may be used to provide confidential, detailed information concerning the manufacturing, processing, packaging and storing of human drug products. Notably, the release of this draft guidance comes on the heels of a recent executive order by President Trump aiming to curb the use of agency guidance documents to avoid the formal rule-making process.

View the full Alert on the Duane Morris LLP website.

FDA Adds Useful Information to the ANDA Paragraph IV Certifications List for Better Transparency and Predictability

The U.S. Food and Drug Administration took another step to implement its Drug Competition Action Plan on June 18, 2019, by updating the information provided in the Paragraph IV Certifications List. The updated list will provide greater transparency regarding Paragraph IV certifications and potential exclusivities. That transparency will in turn lead to greater predictability for generic manufacturers regarding the potential timing of approval for their ANDAs and the potential degree of competition. The additional information will also give the public better insight into the status of generic regulatory exclusivities and the potential future availability of lower-cost generic alternatives for specific drug products.

View the full Alert on the Duane Morris LLP website.

FDA Estimates for Formal Meetings Show Continued Growth of Biosimilars in the United States

Among the key aspects in the development of a biosimilar product for the U.S. market is taking advantage of formal meetings with the U.S. Food and Drug Administration to gain insight on moving a clinical development program for a proposed biosimilar product forward. Tracking meeting requests is also one way to measure the prospects for growth and health of the U.S. biosimilars industry. By that measure, the prospects for the U.S. biosimilars industry look bullish. This year, FDA revised its estimate for meeting requests upward by six respondents to Center for Drug Evaluation and Research (CDER) meeting requests, reflecting the industry’s confidence in the growth of biosimilar market share in the United States.

FDA’s upward projection is consistent with independent estimates of potential biosimilar cost savings in the United States. In 2014, Rand Corporation estimated biosimilar cost savings over the next decade to be $44 billion. By 2017, Rand Corporation estimated biosimilar cost savings over the next decade to be $54 billion. The increase in estimated cost savings is premised on biosimilars gaining in market share of biologics prescriptions. These signs are all pointing toward increased growth of the U.S. biosimilars industry.

Read the full text of this client Alert, including lists of what to have prepared for meeting requests and the actual meetings, on the Duane Morris LLP website.