§ Mr. Wareingasked the Secretary of State for Social Services if, in the light of the findings of the United States 220W Food and Drugs Administration, he will review the continued use of Depo Provera; and if he will make a statement.
§ Mr. Kenneth Clarke[pursuant to his reply, 12 November 1984]: A public board of inquiry set up by the United States Government Food and Drugs Administration has, I understand, recommended that Depo Provera should not be licensed in the US for long-term contraceptive use because it considered there was insufficient evidence of the long-term safety of the product. The present position is that the FDA is considering the report, which we have not yet seen. I understand that the manufacturer of Depo Provera intends to file an exception to the recommendation. We will study the board of inquiry's report and the FDA's decision on it as soon as this is known.
We originally refused to license this drug for long-term contraceptive use in 1982. However, evidence of the safety of Depo Provera, including, I understand the evidence considered by the United States board of inquiry, was reviewed in the United Kingdom by a special panel, chaired by Professor Rosalinde Hurley, which held a hearing in public on the issue in 1983 and reported to the Health Ministers in April 1984. As I explained to the House on 11 April 1984 at c. 281–283 we decided that, in the light of the panel's report, Depo Provera should be licensed in the United Kingdom for long-term contraceptive use only where other forms of contraception are unsuitable and subject to certain safeguards. We would review this decision in the light of any significant new evidence about it we received as we would review the licensing of any other drug in such circumstances.