Counterfeit Drug Penalty Enhancement Act of 2012

Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 3668) to prevent trafficking in counterfeit drugs, as amended.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days to revise and extend their remarks and include extraneous material on the bill under consideration.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I thank Mr. Meehan of Pennsylvania and Ms. Linda Sanchez of California for their work on this issue. This is a bipartisan, bicameral bill. Similar legislation sponsored by Senator Leahy was approved by the Senate last March by voice vote.

This bill enacts penalties for trafficking in counterfeit drugs similar to those for trafficking in military goods and services, as established in the National Defense Authorization Act, which Congress passed last December.

Counterfeit military goods affect the credibility of the supply chains that support our national defense, and counterfeit drugs call into doubt the credibility of America's pharmaceutical legal drug supply. In both situations, the significant and multiple dangers to the public demand enhanced penalties.

Counterfeit drugs are fake drugs. They may be contaminated, contain the wrong ingredient or no ingredient at all, or have the right active ingredient but the wrong dose. They are intentionally packaged to convince the consumer they are genuine. Counterfeit drugs are illegal and can be harmful to a person's health and even deadly.

Counterfeit drugs present not only a financial loss to the manufacturer or mark holder, but also a real health risk to consumers.

While current law technically includes counterfeit drugs, the law does

not expressly prohibit trafficking in counterfeit drugs and carries a maximum penalty of only 10 years.

Late last month, the U.S. Food and Drug Administration warned consumers and health care professionals about a counterfeit version of Adderall that is available for sale on the Internet. Approved for treatment of attention deficit hyperactivity disorders, this medication is a prescription drug classified as a controlled substance, a class of drugs for which special controls are required for dispensing by pharmacists. The FDA's preliminary laboratory test revealed that the counterfeit version of this drug contained the wrong active ingredients. The counterfeit product contained none of the four active ingredients found in the genuine medication. In fact, it contained two different drugs found in medicines used to treat acute pain.

Rogue Web sites and corrupt distributors now prey on the fears of Americans when medicines are in short supply. Drug shortages have increased in frequency and severity in recent years and adversely affect patient care. An unfortunate and potentially deadly side effect of drug shortages is counterfeit drug trafficking.

Last February, the FDA warned health care professionals and patients about a counterfeit version of Avastin, a cancer treatment. Tests revealed the counterfeit version did not contain the medicine's active ingredient. This may have resulted in patients not receiving needed cancer therapy. Several medical practices in the United States may have purchased the counterfeit drug from a foreign supplier. The FDA requested that the medical practices stop the use of any remaining products from this supplier. Unfortunately, in this case alone, there were dozens of cancer patients who may never know that they did not receive lifesaving cancer drugs. Instead, they got a useless counterfeit drug, a drug counterfeited and sold only for the purpose of financial gain. These recent situations prove that those who traffic in counterfeit drugs should be subject to enhanced penalties.

I urge my colleagues to support this bicameral legislation, and I reserve the balance of my time.

Mr. Speaker, I yield as much time as he may consume to the gentleman from Pennsylvania (Mr. Meehan), who is the sponsor of this legislation.

I yield back the balance of my time.

I thank the chairman.

Mr. Speaker, I rise today in support of H.R. 3668, the Counterfeit Drug Penalty Enhancement Act.

I want to thank the distinguished gentleman from Texas for his leadership on this issue on the Judiciary Committee, and I also want to thank my colleagues from the other side of the aisle as we rise in a truly bipartisan, bicameral fashion in working for the passage of this very important legislation. So I appreciate the kind remarks of the gentlelady from California in support of this bill as well.

Like so many other health care costs, prescription drugs are expensive, and the cost is rising. So what we are beginning to see increasingly is people going online to make the purchases of those drugs. It's an issue that I saw firsthand as a Federal prosecutor who began to work on the proliferation of illegal drug sales over the Internet. Oftentimes, the people who are purchasing these are senior citizens.

Online, there are not the kinds of protections that would exist traditionally as there are in a pharmacy setting where, not only do you have the ability to have the advice of a pharmacist, but the certainty of the chain of custody, so to speak, for the drugs that have been traveling in commerce.

What we are finding is that close to 90 percent of counterfeit drugs are sold online. And we're not just talking about mislabeled pills here. The fakes could actually contain no active ingredients, the wrong active ingredient, or even a contaminant.

The counterfeit medicines pose a threat because of the conditions under which they are manufactured, often in unregulated locations and frequently under unsanitary conditions. In many instances, they contain none of the active pharmaceutical ingredients found in the authentic medicine or are in incorrect doses. In others, they may contain toxic ingredients, such as heavy metals, arsenic, pesticides, rat poison, brick dust, floor wax, and even leaded highway paint. In a worst-case scenario, the medicine itself is a fake, and the result of the counterfeit sale is harm to the patient's health and safety.

And while all types of drugs are counterfeited, what's of particular concern to me is the illicit market in significant drugs, cancer drugs, like Avastin and Altuzan; ADHD drugs, like Adderall; and pain treatments, like Vicodin.

This is an economic harm. Estimates are that there are $75 billion worth of counterfeit drug sales annually. But it's not just the economic harm that is of the greatest concern to me; it is the consumer safety associated with this.

The World Health Organization, in their estimates, predicted or believed that counterfeit drugs caused 100,000 deaths worldwide last year. This is an

issue of such importance, it even captured the attention of the world governments, with the G 8 leaders at Camp David issuing a declaration on the need to address this international crisis.

Today it's illegal to introduce counterfeit drugs into interstate commerce, but the penalties are no different than those assessed for trafficking other counterfeit products, such as movies or fashion products like purses.

That's why our bill seeks to have sentencing laws reflect the seriousness of the crime. The bill increases fines to a maximum of $4 million for the first offense and $8 million for subsequent offenses, and prison terms for a maximum of 10 to 20 years. This is an overdue and needed change--and I can say that as a prosecutor.

I would like to thank Congresswoman Sanchez for her leadership on this issue. I want to thank my colleague from Pennsylvania, Congressman Tom Marino, for his hard work on the Judiciary Committee, working with Chairman Smith on this issue. And I want to thank the Members in both parties that should be recognized for bringing this critical measure to the floor so expeditiously.

I encourage my colleagues on both sides of the aisle to lend their support for this very important legislation.

Mr. Speaker, I yield myself as much time as I may consume.

Mr. Speaker, H.R. 3668, the Counterfeit Drug Penalty Enhancement Act of 2012, would increase the maximum criminal penalties for trafficking in counterfeit drugs. Counterfeit drugs are a serious public threat to all Americans for several reasons.

To begin with, a person who unknowingly consumes a counterfeit medication may be harmed by dangerous but undisclosed substances in the drug. As a Food and Drug Administration representative testified at a hearing before the Judiciary Committee's Crime Subcommittee, ``a counterfeit drug could be made using ingredients that are toxic to patients and processed under poorly controlled and unsanitary conditions.''

Also, an individual who consumes a counterfeit drug is deprived of meaningful treatment that can respond to life-threatening illnesses. Consider, for example, a patient suffering from a heart ailment or a child who is desperately fighting an aggressive life-threatening infection. The consequences of consuming an ineffective counterfeit drug are blatantly obvious.

By receiving these counterfeit drugs instead of the real medications that they require, each of these individuals would be denied receiving the effective treatment that they must quickly be given in order to address their illnesses.

Finally, the proliferation of counterfeit drugs poses a grave nationwide risk to the public health and safety of all of our citizens. Current technology and distribution channels present the real danger that a very large quantity of these counterfeit drugs could enter into the marketplace where they can injure and possibly risk the lives of many Americans before they are even detected.

The Food and Drug Administration is working with medical product supply chain stakeholders to respond to this emerging threat, but we need to do more. It is critically important for us to reinforce our criminal law so that it clearly addresses the national menace presented by large-scale, intentional trafficking in counterfeit drugs.

Under current law, trafficking in counterfeit drugs receives the same criminal penalty as trafficking in other less dangerous items. This shortcoming in current law explains why the U.S. Intellectual Property Enforcement Coordinator supports H.R. 3668, as stated in her recent annual report to Congress.

This bill not only appropriately recognizes the need to treat crimes involving counterfeit medications more seriously, but also requires the Justice Department to prioritize its investigatory and prosecutorial efforts with respect to these crimes.

I am particularly pleased that during the Judiciary Committee's markup of the bill, an amendment offered by my colleague, Congressman Bobby Scott, was adopted that would direct the Attorney General to give increased priority to efforts to investigate and prosecute these offenses.

As amended, this measure appropriately recognizes that, while penalty increases may be warranted, effective deterrence depends mostly on the likelihood of apprehension and conviction of offenders.

I commend the efforts of my colleagues, Congressman Patrick Meehan and Congresswoman Linda Sanchez, for introducing this important legislation.

I urge my colleagues to support H.R. 3668, and I reserve the balance of my time.

Mr. Speaker, I yield back the balance of my time.

Mr. Speaker, I rise in support of H.R. 3668, the Counterfeit Drug Penalty Enhancement Act. I have worked with Representative Meehan, worked for quite a while on this issue and it's rewarding to see that bipartisan, practical ideas still have a place in this body.

H.R. 3668 will raise the penalties for counterfeit medicines, a unique consumer health and safety problem. This legislation is needed, bipartisan, and non-controversial.

Counterfeit drug enterprises jeopardize the public's safety and I believe perpetrators should be held accountable.

Unlike other consumer goods, counterfeit medicines pose a significant public health and safety threat to the innocent, sick patients who receive them.

H.R. 3668 will help protect seniors and children, who are uniquely vulnerable, as well as anyone who could be harmed by fraudulent medicines.

We must have tougher penalties for crimes that are a threat to public safety.

H.R. 3668 ensures this and I encourage my colleagues to support this straightforward, reasonable approach.