Generic Biologics Bill

Rep. Henry Waxman (D-Calif.), Sen. Charles Schumer (D-N.Y.), and Sen. Hillary Rodham Clinton (D-N.Y.) have reintroduced the “Access to Safe Medications Act,” which would require the FDA to establish a process for abbreviated approval of generic biologic drugs such as generic insulin. “Biologics treat some of the most devastating diseases around, and no one should be denied access to them because they're too expensive,” Sen. Schumer said in a statement. “Our legislation will allow all Americans to take advantage of these drugs by enabling competition in the market to lower the price and ending permanent monopolies over biologic products. It is high time for these vital treatments to become more affordable.” The Generic Pharmaceutical Association, which represents generic drug manufacturers, expressed “strong support” for the measure, which was first introduced last year. Critics of abbreviated approval contend that generic versions of biologic drugs are not as simple to make as other generic drugs and therefore should require more stringent approval processes than other generics, including additional clinical trials. The bill leaves it up to the Health and Human Services secretary to determine on a case-by-case basis how many additional trials will be required.

U.S. Gets Poor Marks in Prevention

Although the U.S. health care system is generally improving, providers have a long way to go in preventive care, according to the Agency for Healthcare Research and Quality. Two reports from AHRQ, the National Healthcare Quality Report and National Healthcare Disparities Report, found that, for example, only 48% of adults with diabetes received all three recommended screenings—glycosylated hemoglobin tests, foot exams, and eye exams—to prevent disease complications. AHRQ estimates about &dollar;2.5 billion could be saved each year by eliminating hospitalizations related to diabetes complications. The reports also found that fewer than half of obese adults reported being counseled about diet by a health care professional, despite the fact that the U.S. Preventive Services Task Force recommends “intensive counseling and behavioral interventions” for obese adults. “It's encouraging to learn that overall quality continues to improve,” said Dr. Carolyn M. Clancy, AHRQ director, in a statement. “At the same time, the message is clear: Much more can be done to prevent illness from occurring or progressing.”

More Americans Donating Organs

The percentage of Americans agreeing to become organ donors as indicated on driver's license or donor cards is increasing, the Health Resources and Services Administration announced. A Gallup Organization survey commissioned by HRSA, which directs federal efforts to promote organ donation, found that 53% of Americans listed themselves as donors in 2005, almost double the 28% who reported doing so in 1993. Nearly all (97%) of the 2,000 survey respondents said they would donate a family member's organs if they knew the person's wishes ahead of time. The 2005 survey also found that 71% of respondents had notified a family member about their donation wishes, up from 52% in 1993.

FDA's &dollar;2 Billion Budget

The Bush administration is requesting &dollar;2.1 billion for the Food and Drug Administration in fiscal 2008, a 5% increase from the previous year's request. The agency still has not received its final appropriation for fiscal 2007, so the exact amount it will receive for that year is not known yet. The budget includes &dollar;444 million in user fees from industry, including a new program to charge generic drug makers fees to review their products. The agency estimates that generic companies will contribute &dollar;16 million in fiscal 2008. In a statement, Generic Pharmaceutical Association CEO Kathleen Jaeger said the decision to seek user fees “will not bring generic medicines to consumers faster as long as brand companies are still permitted to use tactics that delay market entry.” The budget also includes &dollar;11 million for improving drug safety (this does not include user fee funds that will also go to that effort) and &dollar;7 million to boost medical device safety and to speed up device review. The agency also is requesting &dollar;13 million to move about 1,300 employees of the Center for Devices and Radiological Health to offices at the FDA's new White Oak, Md., campus. The FDA has been gradually moving its operations to the new facilities. The Washington-based consumer-, patient-, and industry-supported Coalition for a Stronger FDA said the budget did not go far enough. It is seeking at least &dollar;175 million more, including greater increases for food, drug, and medical device safety.

More EHRs Obtain Certification

The Certification Commission for Healthcare Information Technology (CCHIT) has given its stamp of approval to 18 more electronic health record products for office-based physicians, bringing the number of certified products to 55, or about 25% of companies in the market, according to a CCHIT estimate. Among the next steps at CCHIT is the expansion of EHR certification to products that cater specifically to certain professional specialties, care settings, and patient populations. “Electronic health record companies have stepped up to the plate, ensuring that their products meet CCHIT criteria,” Dr. Mark Leavitt, chairman of CCHIT, said in a statement. “The benefits of certification will increase as we continue to raise the standards of functionality, interoperability, and security.” A full list of certified products is available online at

www.cchit.org

Policy & Practice