Q. Will FDA be requesting new legislation to prevent counterfeiting from increasing?

A. There are clear opportunities to do a better job protecting drug products from counterfeiters using modern technologies. New approaches that were not possible when the Prescription Drug Marketing Act (PDMA) was implemented 15 yrs ago are available or on the horizon. FDA does intend to work with Congress to stiffen penalties for those who counterfeit drug products.

IV. Read the newspaper article and identify its main idea.

Drug counterfeiting has been relatively rare in the United States, but the practice has increased in recent years. The Food and Drug Administration has stepped up its efforts to halt drug counterfeiting and has issued a report highlighting critical elements that will help keep the U.S. drug supply safe and secure.

The report, released by Health and Human Services Secretary Tommy G. Thompson in February 2004, uses a multi-pronged approach to address weaknesses in the drug distribution system. The report’s recommendations include:

§ New technologies. The FDA believes radio frequency identification (RFID) tagging of products is feasible by 2007, and could be an effective way to tract and trace drugs from the point of manufacturing to the point of dispensing. RFID places electromagnetic chips and tags containing a unique serial number onto cartons and individual drug products. Other important anti-counterfeiting technologies include color-shifting inks, holograms, and chemical markers incorporated into a drug or its label.

§ Stricter licensing requirements. The FDA is working with the National Association of Boards of Pharmacy on revising model state rules for licensure of wholesale drug distributors to make it more difficult for illegitimate wholesalers to get into business.

§ Tougher penalties. The task force found that penalties for counterfeiting drugs are substantially less than for other types of counterfeiting, such as counterfeiting registered trademarks. For example, counterfeiting a prescription drug label that bears a registered trademark is punishable by up to 10 years in prison, while counterfeiting the drug itself is punishable by a maximum of three years in prison. The FDA has requested that the United States Sentencing Commission increase criminal penalties for manufacturing and distributing counterfeit drugs.

§ More secure business practices. Effective protection requires everyone in the drug supply chain to adopt secure business practices and to refuse to do business with people of unknown background. The FDA also recommends that businesses identify individuals and teams to take responsibility for security. Additionally, the FDA intends to increase its inspections of repackages who follow procedures that place them at increased risk for the introduction of counterfeit drugs.

§ Increased education. The FDA plans to increase education for consumers and health professionals about the risks of counterfeiting. The agency will develop educational materials, partner with organizations, and deliver messages through public service announcements and its Web site (www.fda.gov).

§ International collaboration. Counterfeit drugs represent a global challenge. The FDA does not have the legal authority or resources to assure the safety and effectiveness of drugs purchased outside of the United States. The agency intends to work with the World Health Organization (WHO), Interpol, and other international organizations on worldwide strategies to combat counterfeiting.

§ Improved reporting systems. If counterfeit drugs get into the system, there should be procedures in place to recognize the problem and quickly alert the public. Last year, the pharmaceutical industry announced a voluntary program in which companies agreed to notify the FDA’s Office of Criminal Investigations of suspected counterfeiting within five working days. The FDA also encourages pharmacists and other health professionals to report suspected counterfeit drugs to MedWatch, the agency’s program for reporting safety information and adverse events. And the FDA has announced the creation of a Counterfeit Alert Network, a group of organizations that will spread the word about counterfeiting incidents and general educational messages from the FDA. Several organizations have joined the network, including the American Pharmacists Association, the American Medical Association, the American Society of Health-System Pharmacists, the National Consumers League, and the Academy of Managed Care Pharmacy.

It is not a victimless crime. It isn’t an offense against trademarks, or the balance sheets of deep-pocketed pharmaceutical companies. Counterfeit drugs hurt people. And the victims are most often people who need real, quality drugs the most: cancer patients, AIDS patients, and people being treated for heart disease. Moreover, those who have ended up with counterfeit drugs didn’t necessarily go shopping for cheap pills from questionable sources. Many bought them at their local pharmacy. No one knows how many people have taken counterfeit prescription drugs in the U.S., although the number could be surprisingly high. In 2003, the FDA announced a recall of some 200,000 bottles of Lipitor (a popular cholesterol-lowering drug) that were believed to be fake. Over the previous two years, 110,000 bottles of counterfeit Epogen and Procrit, drugs used to boost red blood cell production in people with cancer, AIDS, and kidney disease, made their way into the marketplace. Law enforcement officials recovered only one-tenth of the counterfeit drugs. In the latter case, the drugs patients got were highly diluted. In another instance, a man thought he was injecting himself daily with an AIDS medicine when he was actually taking a female pregnancy hormone. Others who have received counterfeit prescription drugs still have no idea what they really took.

VII. Render the newspaper articles into English.