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 The guidance is intended to replace a withdrawn draft guidance concerning the compounding of animal drugs initially released in May 2015.
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.”
For the first time since September 1989, federal agencies have issued draft guidance concerning drug master files (DMFs), submissions to the FDA that may be used to provide confidential, detailed information concerning the manufacturing,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 Notably, the release of this draft guidance comes on the heels of a recent executive order by President Trump aiming to curb the use of agency guidance documents to avoid the formal rule-making process.
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.
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.