|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 10-19-2006
FDA Creates Express Lane for Approving Some Generic Drugs
Los Angeles Times, 10-19-06
The FDA recognizes that generic drugs are a valuable asset for consumers, and the agency is making an effort to streamline its approval process for "high priority" generics, such as first generic alternatives to a drug whose patent has expired, or generics that will alleviate a national shortage. Previously, the FDA reviewed applications for generics on a firstcome, firstserved basis.
The Food and Drug Administration will accelerate its reviews of certain generic drugs, a top agency official said Wednesday, a move the industry said could help get some cheaper alternatives on the market sooner.
Companies will be given priority if their application is the first one proposing a generic version of a brandname drug that is no longer protected by a patent or market exclusivity, said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research.
Applications filed before a patent or exclusivity ends will not be eligible under the new procedures, which have already been implemented.
Generic medicines that would address a public health emergency or nationwide shortage will also see faster reviews, he said. "We recognize that there are certain situations under which it is advantageous to public health to expedite certain applications," Galson said.
The FDA has a backlog of more than 800 generic drugs awaiting approval under the current process that evaluates all applications in the order it receives them. In 2005, the median time for an approval was more than 16 months, according to the FDA.
Last year, the FDA received 766 generic applications, the agency said. About 40 applications a year are for those that, if approved, would be the first generic alternative to a branded drug. The cause of the backlog is a lack of staff and funding, the FDA and others have said. Reviews for brandname drugs are funded in part by company fees, but the FDA's work on generic bids is funded solely by the government.
"The resource constraints combined with an increased workload in the generics program is a double whammy," Galson said. "Particularly in this era of tremendous importance of saving healthcare dollars, we just can't fall behind."
Confident Democrats Draft Broad Health Care Agenda
The New York Times, 10-20-06
The Democrats are already crafting the outlines of their legislative agenda, should they retake Congress, and the Times gives us a window into their thinking.
A Democratic priority is to renew and expand the Children’s Health Insurance Program, created with bipartisan support in 1997. Democrats say Congress must provide more money just to preserve coverage for the four million children already enrolled.
Federal officials say that two–thirds of uninsured children are eligible for Medicaid or the Children's Health Insurance Program. Democrats want to help states find those children.
The Congressional Budget Office assumes that the budget for the child health program will continue at its current level of $5 billion a year, but Democrats say that would threaten recent gains in coverage. The number of uninsured children fell to 7.9 million in 2004, from 11 million in 1998, but grew last year by 361,000.
Democrats also vow to step up spending at the National Institutes of Health. The agency's budget had doubled over five years, reaching $27 billion in 2003, but has risen less than 6 percent since then.
With additional seats in the House and the Senate, Democrats say, they would overturn restrictions that Mr. Bush imposed on research involving embryonic stem cells. Congress passed such legislation this year, but Mr. Bush vetoed it.
Democrats have a long list of federal agencies, programs and industries they want to investigate. Many are eager to look into drug prices and marketing practices. They also want to investigate whether Medicare overpays managed care plans, compared with spending for similar beneficiaries in the traditional Medicare program.
Mr. Stark, the senior Democrat on the Ways and Means Subcommittee on Health, said his priority was to stop what he called "the Republican drive to privatize Medicare."
All in all, however, their plans seem rather modest, as one might expect. In reality, there is no silver bullet for health care, and the balance of power in Congress is not likely to tip so far as to enable revolutionary change. And, last but not least, the President can always veto legislation that he deems unwise.
But there are changes that would probably find bipartisan support, particularly on Medicare reform. For instance, in 1999 the National Bipartisan Commission on the Future of Medicare, came up with a series of sensible Medicare reforms modeled in part on the health care options available to federal employees. At the time, the Commission said that
Our proposal would allow beneficiaries to choose from among competing comprehensive health plans in a system based on a blend of existing government protections and market-based competition. Unlike today's Medicare program, our proposal ensures that low income seniors would have comprehensive health care coverage.
Unfortunately, the Commission's findings went largely unnoticed at the time, but any Democrats—or Republicans—in the next Congress who are serious about health care reform could do far worse than to brush them off for a closer look.
Plans Help to Close the Gap
Houston Chronicle, 10-21-06
Wal–Mart, and its competitor's like Target, should be applauded for setting low, flat fees for many generic drugs (Wal–Mart's program offers over 140 generics at $4 for a 30 day supply). These programs should help Americans without health insurance, and seniors who run into the "doughnut hole", find inexpensive options for generic medicines. Wal-Mart's program is currently available in 27 states.
Discount plans for generic drugs that several big retailers rolled out in Texas this week offer help for people without health insurance.
But they could also help senior citizens who have drug coverage under Medicare, because of a gap in that coverage.
Earlier this week, Wal–Mart Stores expanded a generic drug plan that offers a monthly supply of 143 drug compounds for $4. Others, including Target and H–E–B, announced rival plans.
Many Medicare holders don't need access to discount plans because they have to pay only about $3 out of pocket for most of the drugs on the list. But a consumer advocate said those who have reached the coverage gap, known as a "doughnut hole," may find it convenient to switch to Wal–Mart or H-E-B for certain drugs.
..."Our initial impression is that these kinds of ready–access programs to discount pricing on generic drugs will help an awful lot of families," said Ron Cookston, director of Gateway to Care, a coalition of more than 60 health care and social service providers, groups and community organizations in Houston. "If nothing else, it's bringing to the attention of the general public the cost savings associated with generics."
According to the Generic Pharmaceutical Association, generics represent 56 percent of the total prescriptions dispensed in the U.S., but only 13 percent of all dollars spent on prescription drugs.
Consumers who have concerns about drug costs can always talk to their doctors about effective generic substitutes, when they are available and appropriate. Generics can be a great value, and generic options will expand rapidly in the next 4-5 years as many "blockbuster drugs" (like Lipitor in 2011) lose patent protection and are exposed to generic competition. The FDA has also moved to streamline its approval process for generic drugs, which will make even more options available for consumers.
Now, if only there was only as much competition between doctors and hospitals as there is between branded and generic drug manufacturers, health care costs might really come down.