Shortly after the 1984 Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman) was passed (the legislation that greatly expanded the universe for generic drug products), and even before the first generic under the new legislation was passed, a campaign was initiated to undermine the public’s confidence in generic drugs. Major pharmaceutical companies began petitioning the Agency with frivolous claims that the system for determining bioequivalence was not sufficiently robust to clearly determine that a generic was truly therapeutically equivalent to its brand name counterpart.
Attempts to access the Federal Register sites, where many of the pre-publications for important FDA business, regulatory actions, proposed and final rules and regulations, petitions and the like are published is met with the following notice:
Due to the shutdown of the Federal Government, National Archives facilities are closed, websites and social media are not being updated or monitored,
In 2018, the FDA says it approved fifty-nine new molecular entities, which included a whopping thirteen biosimilar products. All of the NME product approvals can be found here.
It is important for you the read the FDA explanation of how the Agency is defining NMEs for the purposes of this report and stay focused on the regulatory implications versus the practical implications of how the FDA is classifying this term.
Despite the shutdown, it appears that the OGD is still pumping out ANDAs and updating required statistical metrics as it chugs along under what must be stressful conditions.
November 2018 (Month 2 of FY 2019) showed just four ANDAs received refuse-to-receive actions (four for standard ANDAs and one for a priority ANDA. The OGD acknowledged ninety ANDAs and of the ninety‑nine approved ANDAs in November,
Recently, the ICH has communicated the intention to develop a new ICH Quality Guideline, ICH Q14, on Analytical Procedure Development, and revise the ICH Q2(R1) Guideline on Validation of Analytical Procedures (here), where ultimately both documents may be combined into one document.
This is welcome news as ICH Q2(R1) is long overdue for revision (current version finalized November 2005).
With the holidays, vacations and the partial government shutdown, OGD did not do too badly, with total approval actions of 82 and still a workday to go (and there are always those pesky approvals or tentative approvals that show up after the final bell). This looks to be one of those “down months” that Cook talked about (I might add there have not been many of them recently),
Linaclotide capsules are “minimally absorbed with negligible systemic availability following oral administration. Concentrations of linaclotide and its active metabolite in plasma are below the limit of quantitation after oral doses of 145 mcg or 290 mcg were administered. Therefore, standard pharmacokinetic parameters such as area under the curve (AUC), maximum concentration (Cmax), and half-life (t½) cannot be calculated.” Its site of action is locally in the bowel and intestines.
To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year. The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as we follow the ever-changing landscape of FDA regulatory science,
Ricki Chase, Director, Compliance Practice, authored an article published in Medtech Insight, “How Device Makers Can Leverage FDA Data to Uncover The Agency’s Current Thinking on Compliance”. In this article, she discusses how manufacturers can use information available online from inspectional observations, warning letters, and product recalls to ascertain FDA’s priorities with regards to compliance and enforcement actions.
It looks like Senator Elizabeth Warren thinks it is a good idea! (see here!) I think it is poppycock! Just think of the problems we have now with drug shortages and recalls. The stringent nature of the cGMPs and pharmaceutical manufacturing, in my opinion, do not lend well to government intervention. What a conflict of interest the FDA Office of Regulatory Affairs would have in inspecting the government manufacturing operations!
It appears that 128 is the magic number for the OGD as last month they also had 128 approval actions. November numbers saw a different split between full approvals and tentative approvals (99 and 29, respectively). The 128 total approval actions obviously ties last month record number of approval actions for a single month.
Many thanks to the FDA for publishing several important new and revised guidances and a proposed rule related to the Biopharmaceutical industry this week. These include a finalized version of the “Deemed to be a License” Guidance for industry (here) with several important revisions and additions relative to the previously published draft,
After just over five years, the FDA is officially withdrawing its controversial proposed labeling rule for generic drugs. The advance publication notice in the Federal Register can be found (here). The proposed rule would have permitted ANDA holders to unilaterally revise its labeling via a CBE-0 supplement to include new or different safety information or warnings.
Today, the FDA made final and released a revision to a 2016 draft guidance titled Data Integrity and Compliance With Drug CGMP Questions and Answers (here). The document was revised “based on comments made to the draft as well as requests for FDA thinking on current best practices and additional examples.”
The guidance does have additional examples and clarifying language.