Health and Human Services (HHS) Secretary Tommy G. Thompson announced new Food and Drug Administration (FDA) regulations to streamline the process of making safe and effective drugs available to the public. Now drug companies have a set amount of time before a generic version can enter the market, and the FDA is also changing its review procedures to improve the speed and lower the cost of determining the safety and effectiveness of new generic drugs. Reducing expensive lawsuits over drug patents and smoothing out the approval process will help lower national health care costs because it will reduce costs associated with bringing safe and effective generic drugs to market.

"These changes will enable consumers to save billions of dollars each year by making it easier for generic drug manufacturers to get safe and effective products on the market when the appropriate patent protection expires," explained Secretary Thompson. "The increased availability of lower-cost generic drugs will benefit all Americans, especially seniors."

The "innovator" drug company can only have one 30-month delay in approval for each generic drug application (if the innovator sues the generic company over patent issues). Typically, the FDA can approve generic drugs for the public as soon as the patent protection on brand-name drugs expires, if a court determines that the generic drug will not infringe on the innovator's patent or if the patent is invalid. The generic drug manufacturers must show that their products are as therapeutically equivalent to the approved brand-name drug with regards to safety, strength, performance, quality, purity, intended use, etc.

In the past, generic versions of certain important drugs were kept from the market by multiple, consecutive patent challenges. Some brand-name makers have used the law to file questionable lawsuits to trigger the automatic 30-month delay, according to a report by the Federal Trade Commission. Another strategy used by certain companies involved multiple overlapping delays to push back the launch of generic drugs beyond 30 months. These multiple 30-month stays prevented FDA approval of generic drug manufacturers' applications for four to 40 months beyond the initial 30-month period, the FTC found.

Easier access to generic drugs can lower health care costs because generic medications usually cost less than brand name drugs. Example: The price of an average-brand prescription medication is $72; the generic version runs a mere $17.

Changes in the regulations alone will save the American public an estimated $35 billion over 10 years since generic alternatives to costly brand-name medications will be made available in less time while avoiding time-consuming legal delays.

President Bush's fiscal year 2004 budget request includes a $13 million increase for the FDA's generic drug program, which is the largest one-year increase ever proposed for the program. The FDA is also implementing other reforms to help reduce the time and cost of generic drug approvals, and to further educate the public about generic drugs.

The proposed increase in the FDA's generic drug budget will allow FDA to hire 40 experts to review generic drug applications more quickly and spark research into the expansion of the range of generic drugs.

In order to improve the efficiency of its review process for generic medications, the FDA is implementing a new system of communication early on with generic drug manufacturers who are submitting applications. These companies will also receive FDA guidance for preparing and submitting quality applications, which could help alleviate potential application problems or confusion before it occurs.

These new changes are expected to reduce the total approval time for most new generic drugs by at least three months over the next three to five years. Most Americans using generic medications stand to benefit because the changes will speed up the approval process.

In order to get the message across to the American public that FDA-approved generic drugs are as safe and effective as their brand-name counterparts, the FDA is expanding its educational programs and partnerships. FDA will undertake additional scientific studies of generic drug "bioequivalence" to quicken the decision of whether a generic copy works in the same way as a specific name-brand.

New regulations will be effective on August 18, 2003.