Washington Report

New FDA Policies Shape Pharma Development and Production

Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634, jwechsler@advanstar.com

Pharmaceutical manufacturing has been in the spotlight for the past few months as a key factor affecting the development of safe and effective prescription drugs. A prominent theme of industry executives and US Food and Drug Administration officials is the importance of identifying critical factors early in the drug research process that may affect drug quality and product reliability. At the same time, FDA has rolled out several new policies and has initiated compliance actions. The need to regain public trust in the safety and quality of pharmaceuticals was a clear message at a number of prominent industry gatherings. In March, the Pharmaceutical Research and Manufacturers of America (PhRMA) held its annual meeting in Washington, moving it north from Florida to signal that it is serious about communicating more effectively with the public and policymakers. The five-year convention of the US Pharmacopeia highlighted drug manufacturing challenges as it met to approve new leaders and set priority objectives for the organization’s next five years. In a number of public presentations, FDA Acting Commissioner Lester Crawford emphasized the agency’s success in modernizing good manufacturing practices (GMPs) as part of his philosophy and approach for ensuring drug safety. He linked FDA’s effort to update GMPs as part of the agency’s Critical Path initiative to overcome impediments to the development and production of important new drugs. He told the USP convention that FDA’s overhaul of GMPs should encourage manufacturers to modernize their methods, equipment, and facilities to eliminate both production inefficiencies and undue risks for consumers. GMP modernization and the Critical Path initiative will help predict eventual product failures and reduce development uncertainties, he predicted, noting that recent GMP changes establish “tougher inspections rules to make them more targeted and effective.” At the annual meeting of Research!America on March 15, Crawford said GMP compliance is critical for ensuring that a quality product can be mass-produced to meet standards. He explained to this organization of biomedical research advocates that FDA recognized several years ago that GMPs were out of date and that drug manufacturing concepts and machinery were obsolete as documented by the hefty fines levied by the agency against leading manufacturers for failure to meet GMP requirements. To improve the situation, FDA moved to “revolutionize the way drugs are manufactured,” an effort that may be the “single most important undertaking of its type in FDA’s history,” Crawford stated. He noted that FDA has presented its GMP modernization proposals to drug regulatory authorities around the world as a way to encourage international harmonization of drug manufacturing standards. Crawford said that FDA plans to issue final revised GMPs for dietary supplements this summer and then will tackle GMP revisions for foods and possibly for medical devices. Crawford estimated that the adoption of more-modern manufacturing systems as a result of FDA’s GMP modernization effort could save the American people $50 billion over the next decade, which would reduce the cost of prescription drugs and encourage new product development. Some analysts predict that more-efficient manufacturing systems could yield savings up to $50 billion a year in the United States and $90 billion annually worldwide. Additional payoffs will evolve from the larger Critical Path program, Crawford noted, as FDA rolls out white papers and proposed rules to implement this ambitious effort to “reinvent” the agency. (continued)