Angie Drakulich

The benefits of harmonization may be on industry's wish list, but buying into change is another story.

Government plans require investment, partnership, and industry collaboration.

FDA Commissioner Margaret Hamburg and US Assistant Secretary for Health Howard Koh released a statement on Sept. 9, 2011, aimed at a stakeholder meeting held at the US Department of Health and Human Services (HHS) to address the growing problem of drug shortages in the United States. The shortages affect many necessary drugs, including those for cancer, anesthesia, influenza, and other critical conditions.

FDA?s Division of Drug Marketing, Advertising, and Communication (DDMAC) issued a letter to Pfizer?s vice-president of US Regulatory Affairs regarding its online resources page for Lipitor (atorvastatin calcium) tablets. The letter, which was brought about as part of the agency?s Bad Ad program, cites that the webpage is misleading because it makes representations and/or suggestions about the efficacy of Caduet (amlodipine besylate/atorvastatin calcium) tablets, Chantix (varenicline) tablets, and Norvasc (amlodipine besylate) tablets without communicating risk information associated with the use of these drugs.

The US Pharmacopeia (USP) continues to expand its collaboration with drug authorities around the world, this time with Brazil?s regulatory agency. USP and the Brazilian National Agency of Sanitary Surveillance (ANVISA) are teaming up to develop joint education activities for professionals involved in formulating and using pharmacopeial monograph standards in Brazil, according to news releases on the USP website.

Inside the National Institutes of Health

Since China?s State Food and Drug Administration (SFDA) revised its GMPs last year (they became effective Mar. 1, 2011), the agency has been making other improvements to enhance the quality of its pharmaceutical manufacturing industry. Many improvements are tied to the 2015 deadline SFDA has placed on existing domestic drug manufacturers to implement the revised guidelines. Newly created companies are expected to meet the new GMPs from the start.

FDA released this week a report from its Center for Drug Evaluation and Research (CDER) that identifies regulatory science needs that will guide CDER?s strategic planning in the years ahead and allow it to fulfill its regulatory mission. The report, Identifying CDER?s Science and Research Needs, discusses internal research initiatives and goals for contributing to the agency?s overall regulatory science efforts.

In early July 2011, FDA provided an update in which the agency said that it has made progress toward implementing the US Food Safety Modernization Act (FSMA), which was enacted in January 2011. In addition to clarifying expectations for new dietary ingredients through new draft guidance, the agency has issued an antismuggling strategy.

At last week?s 2011 Partnering for Global Health Forum, sponsored by the Biotechnology Industry Organization and BioVentures for Global Health, a unique panel of government leaders from emerging markets discussed what it takes to do business in their countries.