Suprol – anything goes?

Suprofen was manufactured by Ortho Pharmaceuticals, a wholly owned subsidiary of Johnson & Johnson. Ortho Pharmaceuticals first filed an NDA for suprofen with the fda in October 1978. That was withdrawn because of alleged irregularities and possible falsification of data by some clinical investigators of the drug (independently of the company), and then re-filed in August 1981. ¹ In 1982 the British regulatory authorities approved the marketing of suprofen for the treatment of pain, including pain in osteoarthritis and rheumatoid arthritis. Use of the drug was indicated for long-term therapy on all the uk-approved data sheets. ² Notably, according to Andrew Veitch, as late as October 1986 a spokesperson for the British regulatory authorities said that they were not aware of any false data submitted to the csm. ³ However, official secrecy under the Medicines Act prevents us from knowing whether or not suprofen was approved partly on the basis of falsified data. Meanwhile, in the us suprofen was developed as a pain killer for arthritis.