The FDA issued a draft guidance Monday to advise drug sponsors on how to properly evaluate post-approval manufacturing changes for unintended consequences. "We know that postmarket changes to manufacturing can reduce the possibility of a supply disruption due to quality problems, lower production costs and improve quality," FDA Commissioner Scott Gottlieb said. "But it's important that manufacturing changes be carefully evaluated to make sure that they don't introduce the potential for adverse impacts on quality that might lead to new safety risks to the patient." The guidance discusses how to assess the risk of changes to the manufacturing process of generics and drugs covered by new drug applications and in drug master files. It also advises on the documentation needed to support the changes. The draft covers facility, scale and equipment changes associated with all steps of drug substance manufacturing; specification changes to starting materials, raw materials, intermediates and the unfinished and final drug substance; synthetic manufacturing process changes; changes in the source of drug substance; and changes to the container closure system of the drug substance. The FDA is opening a 60-day comment period on the draft.
The Office of the U.S. Trade Representative announced that it has secured changes that will reduce the U.S. trade deficit with South Korea and ensure that the 2012 trade agreement between the two countries is a good deal for U.S. workers and businesses. The changes include South Korea amending, this year, its premium pricing policy for global innovative drugs to make it consistent with commitments under the trade agreement and to ensure nondiscriminatory and fair treatment for U.S. biopharma exports.
Three members of a U.K. family pleaded guilty to producing and supplying unlicensed medicines and money laundering. The three ran an online business that, in addition to selling body building supplements, offered drugs for conditions ranging from severe acne to cancer. Enforcement officials with the U.K.'s Medicines and Healthcare Regulatory Agency (MHRA) seized more than 112,000 tablets and 1,884 bottles of injectable liquids from a rented office where they found pill pressing equipment and dyes imported from China. The drugs were made in a cement mixer, the MHRA said. Daniel Hackland and his brother Matthew Hackland were sentenced to 4.5 and 3 years, respectively. Daniel's wife, Jenna Hackland, received a suspended 18-month sentence.