Schering-Plough resolves to secure FDA approval over non-compliance

The chairman and ceo of Schering-Plough, Richard Jay Kogan, has committed the company to securing the confidence of the FDA concerning its 486 non-compliance problems.

The problems stemmed from an FDA inspection last year when the regulatory authority issued a report citing deficiencies concerning compliance with current GMPs, primarily related to production processes, controls and procedures.

The FDA has advised the company that GMP deficiencies cited in facility inspection reports must be resolved prior to granting approval of the company's pending new drug application for Clarinex (desloratadine) tablets, a new nonsedating antihistamine.

Kogan observed that 'this is not a normal time for the company'. Referring to the manufacturing issues, he said, 'We are working through them and I am confident we will come out of this with our fundamental strength intact, wiser and as competitive as ever.

'We are working to complete the GMP initiatives begun in 1999 and are in the process of completing a new, comprehensive, GMP work plan, which takes a broad, systematic approach that will encompass all FDA-regulated manufacturing sites and address six key areas.'

These areas are quality assurance, facilities and equipment, materials management, production, laboratories and packaging and labelling, he said.

On a better note, Schering-Plough's performance for the year 2000 was marked by several major advancements. Sales reached US$9.8bn, up 8% and earnings per share rose 14% to $1.64. The r&d programmes made important progress, with five discovery compounds recommend for clinical development and the company received eight marketing approvals for major products or indications and filed 14 major regulatory applications.

Together with Merck, Ezetimibe, a novel cholesterol absorption inhibitor, is in development for US marketing. Development is focusing on its use in a one-a-day fixed combination tablet with Zocor, Merck's cholesterol-management drug. Results of Phase III monotherapy and co-administration studies are expected to be presented this year.

Schering-Plough also have Peg-Intron, a longer-acting form of Intron A a-interferon, which has been launched in the US and the EU for the treatment of hepatitis C. A combination therapy using the Peg-Intron and Rebetol that is expected to become a new standard care for hepatitis C, was approved in the EU in March, and has been granted priority review status by the FDA.