WASHINGTON - As forecast by policy analysts here, it will take months or even years to begin assessing the real impact of the Medicare law on drug companies and consumers.
In fact, William Testerman, principal with Ernst & Young in Washington and a former senior health policy adviser for Sen. Bill Frist (R-Tenn.), recently told conference attendees at the National Medicare Prescription Drug Congress that the Medicare law was drawn up behind closed doors and contains a number of technical errors that must be corrected before varying sections can be implemented.
The next step in the process will be the release of rules and regulations published for stakeholder or public comments. Testerman said details about the different sections of the law likely would be ready for more discussion at the Biotechnology Industry Organization's annual meeting, held this year in San Francisco in June.
Among the first set of regulations ready for comment are those involving reforms to the Hatch-Waxman Act of 1984, the law that created the generic drug industry. Those reforms are designed to clarify the conditions under which 180-day marketing exclusivity for generics can be given. The period of marketing exclusivity is generally provided to the first generic drug that challenges a patent for the innovator product
The Medicare law also established a limit on how long approval of generic drugs can be delayed while patent rights are being litigated in court. And it limits brand-name companies to one 30-month extension per drug patent.
The FDA is asking the public to comment within 60 days on the reforms that are meant to speed approval of generics. The regulations are published on the Federal Register.
Meanwhile, in response to two citizen petitions, the FDA said its website henceforth will provide more transparent information to help generic manufacturers determine whether they qualify for market exclusivity. Specific information will include the date a company submits an application, the trade and generic name of a drug, its dosage form and the strengths of drug products.
Bush Feeling Heat For Bioethics Decision
The Associated Press reported that presidential candidate Sen. John Kerry (D-Mass.) is taking swings at President Bush for firing two dissenting members of the president's handpicked advisory council on bioethics.
Kerry reportedly charged that the members should be selected based on their knowledge of science and reputation, as opposed to their political leanings.
Bush dismissed William May, an ethics professor at Southern Methodist University, and Elizabeth Blackburn, a cell biologist and professor at the University of California in San Francisco.
The president appointed three new members:
• Benjamin Carson, director of pediatric neurosurgery at the Johns Hopkins Medical Institutions in Baltimore. He is a professor of neurosurgery, oncology, plastic surgery and pediatrics. Carson gained worldwide recognition in 1987 when he served as principal surgeon in the 22-hour separation of the Binder Siamese twins from Germany. That was the first time occipital craniopagus twins had been separated with both surviving. Carson is noted for his use of cerebral hemispherectomy to control intractable seizures as well as for his work in craniofacial reconstructive surgery, achondroplasia (human dwarfism) and pediatric neuro-oncology.
• Peter Lawler, Dana Professor and chair of the department of government and international studies at Berry College in Mount Berry, Ga. He teaches courses in political philosophy and American politics and has won several awards at Berry. He is executive editor of the quarterly journal Perspectives on Political Science and has been chair of the politics and literature section of the American Political Science Association. He has written or edited nine books, including, "Aliens in America: The Strange Truth About Our Souls and Postmodernism Rightly Understood."
• Diana Schaub, associate professor and chair of the department of political science at Loyola College. She has taught at the University of Michigan at Dearborn and has served as assistant editor of National Interest. She is the author of "Erotic Liberalism: Women and Revolution in Montesquieu's Persian Letters,'" along with several book chapters and articles in the fields of political philosophy and American political thought.
Bush's 18-member bioethics council was formed in late 2001 following his decision to allow the National Institutes of Health in Bethesda, Md., to help pay for research on certain stem cell lines existing Aug. 9, 2001. (See BioWorld Today, Aug. 11, 2001.)
The panel's charge is to advise the president, not set policy. For example, in July 2002, the panel voted 10-7 in favor of a four-year moratorium on therapeutic cloning. (See BioWorld Today, July 12, 2002.)
FDA's Drug Information Website
The FDA launched a website to help consumers and health professionals find information about approved drug products more quickly.
Indeed, the agency said drugs@FDA is a searchable database that includes information on approved prescription drugs, some over-the-counter drugs and discontinued drugs. It's located on the web page for the FDA's Center for Drug Evaluation and Research (CDER). The agency said it is the first web resource to offer a comprehensive overview of a drug product's approval history.
The database incorporates information from all parts of CDER's website, including consumer information sheets, medication guides and labeling. Eventually information on recalls, warnings and drug shortages will be included.
The site can be searched using the drug name or active ingredient. Users also can find out if therapeutic equivalents exist, including generics or possibly an over-the-counter drug.