Regulatory in brief | Belgium, France, monographs, US FDA

Regulatory in brief | Belgium, France, monographs, US FDA

17 December 2019 - Deborah Wilkes

Belgium is banning combination cough and cold medicines, France is seeking to ensure safe use of vasoconstrictors, the US Senate has passed key OTC legislation, and the new commissioner of the US Food and Drug Administration (FDA) has been confirmed.

Belgian ban on combinations

Belgium’s Federal Agency for Medicines and Health Products (FAMHP) is banning combination cough and cold medicines from 1 January 2020. The move is in line with measures announced in 2012.

France takes action on vasoconstrictors

The French medicines agency, the ANSM, is seeking to ensure safe use of non-prescription vasoconstrictors by distributing information leaflets to pharmacies and pharmacy customers.

Noting that tablets containing pseudoephedrine were available in France without a prescription, the ANSM said vasoconstrictors were associated with “significant misuse”. Prolonged use for more than five days and non-compliance with contraindications were highlighted by the regulatory agency.

According to the ANSM, vasoconstrictors were associated with rare but serious cardiovascular and neurological adverse effects.

The ANSM said an information leaflet for community pharmacies would be developed and distributed during January 2020. Furthermore, an information leaflet would be available for distribution to pharmacy customers.

Monograph legislation progresses

The US Consumer Healthcare Products Association (CHPA) has welcomed the passage of OTC monograph reform legislation by the US Senate.

“Our nation is one step closer to having a modern OTC regulatory framework that will better serve consumers and facilitate a new wave of innovation in OTC medicines,” said Scott Melville, president and chief executive officer of the CHPA.

The Senate passed the Over-the-Counter Monograph Safety, Innovation and Reform Act of 2019 by a vote of 91-2. It has to be considered by the House of Representatives before being sent to president Donald Trump for signature into law.

Senate confirms Stephen Hahn

The US Senate has confirmed Stephen Hahn as the new FDA commissioner.

The cancer specialist was nominated for the post by president Donald Trump at the start of November 2019 (click here to read the News story).

Commenting on the news, the US Consumer Healthcare Products Association (CHPA) said it hoped Hahn would oversee the release of the “long-awaited proposal for increasing access to OTC medicines using innovative approaches that enable more prescription-to-OTC switches”.

The CHPA added that it was keen to see stronger regulation and enforcement for dietary supplements as well as “decisive FDA action around cannabidiol (CBD)”.

The industry association urged the FDA to “exercise its existing statutory authority to establish a clear pathway for manufacturers to lawfully market CBD in dietary supplements, while also continuing to go after bad actors”.

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