image of children

Last week’s round-up, 13 – 17 April 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud


Pharmeuropa 32.2 just released

17 April 2020

The newly published Pharmeuropa 32.2 draft monographs are open for public consultation until 30th June 2020. The list of monographs can be viewed by following the link below.

These draft monographs will be adopted as official standards for the products concerned in all Ph. Eur. member states, at a later date. Any changes to general texts may also impact monographs as while these are not legally binding, they become mandatory when referred to in a monograph. Therefore, users are highly encouraged to provide feedback on these draft texts.

Any users who wish to provide feedback but are not able to do so by the deadline due to temporary lockdowns and disruptions caused by the current COVID-19 pandemic, are advised to contact:

  • The National Pharmacopoeia Authorities of the Ph. Eur. member state: For manufacturers and other interested parties from member and non-member states of the Ph. Eur. convention, and for multinational interested parties.
  • The EDQM (via its HelpDesk) for industry associations or other associations.

FDA drafts guidance on restricted delivery systems for liquid drugs

16 April 2020

The FDA has drafted guidance on the use of restricted delivery systems for oral liquid drugs, in an effort to reduce the accidental ingestion of liquid drugs by children.

The document provides recommendations for instances when restricted delivery systems should be considered, as well as human factors, design considerations and instructions for the use of medicines with restricted delivery systems. Open and closed flow restrictors are also described in the guidance: Closed flow restrictors limit access to a single-unit volume using a self-closing valve, while open flow restrictors allow for a continuous, controlled volume. According to the FDA, these restricted delivery systems should “reduce the amount of liquid that flows from a bottle in a 5-minute period based on the toxic dose of the drug product to a 2 year-old child”.

Specific recommendations for products containing acetaminophen, dextromethorphan, diphenhydramine, ibuprofen and pseudoephedrine are also included in the draft guidance.

FDA offers guidance for generic drug developers of hydroxychloroquine, chloroquine

15 April 2020

The FDA has issued Product-Specific Guidances for Chloroquine Phosphate and Hydroxychloroquine Sulfate, two anti-malarial drugs that may potentially be used to treat COVID-19.

The hydroxychloroquine sulfate guidance finalizes the draft of the same title released in 2011 and includes additional advice about a Biopharmaceutics Classification System-based biowaiver option. This biowaiver option allows for the consideration of a waiver of in vivo testing provided that certain conditions are satisfied.

The chloroquine phosphate guidance clarifies that the drug is AA rated in the Orange Book, therefore, in vivo studies are not necessary since there are no known or suspected bioequivalence issues. Due to the COVID-19 public health crisis, the FDA has released the chloroquine guidance as final guidance and rather than the usual draft guidance.

Generic ‘identity’ gets lost when companies juggle both generic and brand drugs

14 April 2020

Researchers at Rutgers Law School, Stanford Law School and University of San Diego School of Law, built a comprehensive database of all major branded and generic drug companies, to evaluate where their revenue comes from, how it changes over time, and how it affects their behaviour in court.

Over time, one third of the companies included in the study, adopted mixed business models. These cannot be classified as ‘pure generic’ companies but as ‘mixed generics’, as their revenue is derived from sales of both generic and branded products.

The study has shown that when companies opt for the ‘mixed generics’ model, their behaviour differs from that of ‘purely generic’ companies. According to the study, ‘purely generic’ companies tend to fight harder in court and challenge more patents. While ‘mixed generics’ companies were more likely to settle patent challenges.

These results have implications for antitrust law in the pharma industry since the business model (‘pure generic’ or ‘mixed generic’) adopted by a company may affect the courts’ and antitrust agencies’ evaluation of settlements by which brand firms pay generic companies to delay entering the market.

EC offers antitrust reassurances to generic drugmakers cooperating on shortages

13 April 2020

The European Commission has reassured the generic drug association Medicines for Europe that member and non-member generic companies may need to collaborate and coordinate on stock management and distribution to reduce shortages of important hospital drugs used to treat COVID-19 patients. This was brought on by shortages of non-prescription pain medications due to stockpiling by citizens and the increasing demand for ICU medicines used to treat Covid-19 patients.

Under normal circumstances such collaboration would be contrary to antitrust rules, however, with the appropriate safeguards this coordination can be of benefit to patients during the current pandemic. In view of this, the EC has released ‘Guidelines on the optimal and rational supply of medicines to avoid shortages during the COVID-19 outbreak’, which aim to protect public health and preserve the integrity of the single market, whilst ensuring the supply of necessary affordable medicines in the EU during the COVID-19 pandemic.


Image: Lovely children by Flickr user Linh Lưu Huệ, Public Domain Mark 1.0

Trackbacks and pingbacks

No trackback or pingback available for this article.