Partnership for Safe Medicines Issues Statements on Series of Drug Safety Hearings
Recently, the heparin contamination and drug safety in general have taken center stage on Capitol Hill. In the past two weeks, there has been three hearings in the House and one in the Senate examining issues affecting the safety of our prescription medicines.
As part of our commitment to protecting consumers from counterfeit and contraband medicines, the Partnership issued statements to the media and Congress for each hearing about the government’s role in drug safety and suggestions for protecting Americans moving forward.
Although I applaud the members of Congress who initiated these hearings, their findings shouldn’t come as a surprise. Here at the Partnership for Safe Medicines, we have been saying for months that the FDA’s ability to safeguard America’s food and drug supplies is being compromised by numerous challenges and obstacles.
In our statements, we reiterated our call for strict, rigorous regulatory oversight of imported drugs to keep situations such as the recent heparin contamination from repeating in the future. But more importantly, progress in the fight against counterfeit and contaminated medications is unforeseeable unless we give the FDA all the tools it truly needs to fix the problems.
These hearings were a step in the right direction. But we can’t stop there. It’s essential that Congress and the FDA view the ideas and legislation coming out of these hearings as the beginning of drug safety efforts in our country, not the end.
While the government works to develop a plan to protect Americans, it’s more important than ever before that everyone learns how they can take steps to protect themselves from contraband and potentially counterfeit medicines—because counterfeit drugs are unsafe at any cost. Visit SafeMedicines.org and join us in our stand against counterfeit drugs.
Partnership for Safe Medicines Applauds FDA Reform Bill
WASHINGTON, DC (May 1, 2008) – The Partnership for Safe Medicines, a group of organizations and individuals dedicated to protect consumers from counterfeit medicines, issued the following statement regarding today's hearing on Food and Drug Administration (FDA) Globalization Act of 2008 held by the House Committee on Energy and Commerce’s Subcommittee on Health.
Dubbed by supporters as the “FDA reform bill,” the Partnership for Safe Medicines thanks Rep. John Dingell and other members of the Committee for moving this legislation forward. Recent events have demonstrated that reform is necessary, and overdue.
However, we encourage Congress to view this reform bill and other similar legislation as the beginning of drug safety efforts in our country, not the end. The FDA needs authority to destroy unapproved drugs entering our country rather than returning them to the criminals who sent them here in the first place. We need to require Internet pharmacies to be certified so customers can recognize which pharmacies are legitimate and which are rogues selling questionable items. And, we need to stop online pharmacies from selling a controlled substance over the Internet without a valid prescription.
While the government works to develop a plan to protect Americans, the Partnership encourages everyone to learn how they can take steps to protect themselves from contraband and potentially counterfeit medicines—because counterfeit drugs are unsafe at any cost.
About the Partnerships for Safe Medicines
The Partnership for Safe Medicines is a group of organizations and individuals that have policies, procedures, or programs to protect consumers from counterfeit or contraband medicines. For more information, please visit SafeMedicines.org.
Partnership for Safe Medicines Supports Change in Foreign Inspection Process
WASHINGTON, DC (April 29, 2008) – The Partnership for Safe Medicines, a group of organizations and individuals dedicated to protect consumers from counterfeit medicines, issued the following statement regarding today's hearing on the examination of the events leading up to the distribution of contaminated heparin and Chinese plant inspections held by the House Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations.
The Partnership for Safe Medicines applauds the Subcommittee for recognizing the importance and urgency of eliminating contaminated drugs. Unfortunately, this recent case of heparin contamination is just one example of the increasingly global problem of counterfeit drugs sold to an unsuspecting public.
Today’s hearing is a step in the right direction. It is important to better understand what went wrong and what solutions are necessary to ensure the safety of our prescription medicines. But we can’t stop there. The FDA needs to open permanent field offices in key exporting countries and it must staff those offices with inspectors and criminal investigators armed with the same authority as their State-side colleagues. The FDA needs to be granted the authority to enter and inspect foreign manufacturing facilities without previous notice.
While we reflect on the events leading up to this tragedy, the Partnership encourages everyone to learn how they can take steps to protect themselves from contraband and potentially counterfeit medicines—because counterfeit drugs are unsafe at any cost.
About the Partnerships for Safe Medicines
The Partnership for Safe Medicines is a group of organizations and individuals that have policies, procedures, or programs to protect consumers from counterfeit or contraband medicines. For more information, please visit SafeMedicines.org.
Consumer Protection Group Issues Statement About FDA's Ability to Enforce Safety Regulations
WASHINGTON, DC (April 24, 2008) – The Partnership for Safe Medicines, a group of organizations and individuals dedicated to protect consumers from counterfeit medicines, issued the following statement regarding today's hearing on the Food and Drug Administration’s (FDA) ability to enforce safety regulations held by the Senate Committee on Health, Education, Labor, and Pensions.
The Partnership for Safe Medicines applauds the Committee for recognizing that the FDA’s ability to safeguard America’s food and drug supplies is being compromised by numerous challenges and obstacles. Unfortunately, this recent case of heparin contamination is just one example of the increasingly global problem of counterfeit drugs sold to an unsuspecting public.
We have seen time and time again that unscrupulous suppliers will not hesitate to use foreign, even toxic, materials in a drug's raw materials if it means more money. And it's easier than ever for counterfeiters to use materials of questionable quality to penetrate the U.S. market since criminals are becoming more organized and inventive.
The United States needs to a leader in the global fight against fake drugs. We need to give the FDA all the tools it truly needs to fix the problems, including a dramatic, and sustained, funding increase. We need to work with governments around the world to adopt a tougher stand against the perpetrators of counterfeit medicines that reflects the gravity of their offenses. And we need to send a message to these criminals that we will not tolerate activities to compromise public health.
The Partnership encourages everyone to learn how they can take steps to protect themselves from contraband and potentially counterfeit medicines—because counterfeit drugs are unsafe at any cost.
About the Partnerships for Safe Medicines
The Partnership for Safe Medicines is a group of organizations and individuals that have policies, procedures, or programs to protect consumers from counterfeit or contraband medicines. For more information, please visit SafeMedicines.org.
Partnership for Safe Medicines Issues Statement About FDA Foreign Drug Inspection Program
WASHINGTON, DC (April 22, 2008) – The Partnership for Safe Medicines, a group of organizations and individuals dedicated to protect consumers from counterfeit medicines, issued the following statement regarding today's hearing on the Food and Drug Administration’s (FDA) efforts to inspect foreign drug plants making products for the U.S. market held by the House Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations.
The Partnership for Safe Medicines echoes the concerns expressed by Congressmen Dingell, Barton, Stupak and Shimkus about the state of the FDA’s foreign drug inspection program. There is a strong need for strict, rigorous regulatory oversight of imported drugs to keep situations such as the recent heparin contamination from repeating in the future. However, progress in the fight against counterfeit and contaminated medications is unforeseeable unless we give the FDA all the tools it truly needs to fix the problems.
The FDA needs a dramatic, and sustained, increase in funding in order to properly inspect the foreign manufacturing facilities producing the active pharmaceutical ingredient (API) in America’s drugs. It needs the resources to open permanent field offices in China, India and other key exporting countries staffed with both inspectors and criminal investigators.
This Subcommittee hearing addresses key issues core to our mission – to protect consumers from contraband and counterfeit medicines. The Partnership continues to encourage consumers to learn how to protect themselves from potentially dangerous medicines while Congress and the FDA work together to improve its capacity to properly regulate pharmaceutical importation.
About the Partnerships for Safe Medicines
The Partnership for Safe Medicines is a group of organizations and individuals that have policies, procedures, or programs to protect consumers from counterfeit or contraband medicines. For more information, please visit SafeMedicines.org.
Regulating Online Pharmacies
Bryan A. Liang, MD, PhD, JD
According to some sources, there are at least 1,000 Web sites selling prescription drugs. Of course, not all of which are legitimate. Considering the sheer number of hits an Internet search for "online pharmacy" returns, it's not surprising that the U.S. Senate has put the Online Pharmacy Consumer Protection Act of 2007 on its legislative calendar.
One provision in the Act will prohibit an online pharmacy from selling a controlled substance over the Internet without a valid prescription. This is not an isolated concern. In fact, recently a Utah couple was in the news for their role in an international counterfeit drug operation in which they received and distributed shipments of hundreds of drugs, sometimes thousands of tablets, without a license or doctor's supervision.
As I've noted elsewhere, by confronting the safety issues associated with online drug access, requiring a prescription is step in the right direction. But it needs to go much further. It should require online pharmacies to be certified so customers can recognize which pharmacies are legitimate.
Stories of people who've died after purchasing controlled substances through online pharmacies are tragic. For example, Ryan Haight, a straight-A, talented high school scholar and athlete died because of an overdose of Vicodin, a powerful painkiller that he'd purchased without a prescription through an unregulated Internet seller.
Unfortunately, online drug peddlers prey upon an increasing demand: the National Survey of Drug Use and Health found that 6 million Americans aged 12 or older had used prescription psychotherapeutic drugs nonmedically in the previous month, and 3.1 million had abused OxyContin in their short lives. The bulk of new abusers are in the 12- to 17-year-old age group.
Further, beyond selling drugs of abuse to children, unregulated online pharmacies also maim and injure patients by passing off fakes.
Patients who access drugs through the Internet, who often represent some of the most vulnerable patients including the elderly and minorities, don't know they are not getting the real thing because many diseases are "silent."
Drugs treating high blood pressure, elevated cholesterol, cancer, and other illnesses don't provide immediate or obvious clinical changes after being taken.
Unregulated online sellers represent a lose-lose situation—patients getting the drugs of abuse they want; and patients not getting the drugs of treatment they need.
However, mandating prescriptions alone is not enough. Unscrupulous online businesses will sell whatever to whomever, as long as they are paid. Just as they've embraced counterfeit drugs, they'll also sell fake prescriptions.
Regulating these pharmacies should include verification that consumers have a valid prescription. But these sellers should also be licensed in the state where they sell drugs just like normal pharmacies, and be subject to rigorous oversight standards, such as the VIPPS program--the Verified Internet Pharmacy Practice Site accreditation program created by the National Association of Boards of Pharmacy.
The idea of ensuring that pharmacies verify prescriptions is a good one. But it is only a start. Oversight must include assurances that they are legitimate, have a license, and verify the need for the medications they dispense.
For more information about buying safely online, go to SafeMedicines.org.
Between a Rock and Hard Place
There's no question that prescription drugs save lives, relieve suffering, and promote the quality of life for those with access to them. There's also no question that, to be helped by these drugs, patients have to be able to afford drugs that are safe and effective.
Unfortunately, current public policy puts patients in a Catch 22 by not effectively addressing either the issues of safe drug availability or affordability. Policymakers focused on drug prices fail to address safety and, on the other hand, those focused on safety fail to address high prices.
According to a recent GAO report and hearings we've talked about in this blog, the FDA isn't able to address the vulnerabilities that allow counterfeits and diverted drugs to enter into the supply chain. Technology focuses on tracking the cardboard packaging of our medicines, not the product. And patients who cannot afford legitimate drugs are increasingly being driven to questionable and unsafe medication sources that expose them to the dangers of counterfeits.
The combination of high prices and limited protections makes the U.S. an attractive market to counterfeiters who can produce fakes at virtually no cost and little risk of being held accountable. This results in huge profits compared to other activities available to the counterfeiter with virtually no chance of being caught.
With growing incidents of counterfeit drugs making their way into the worldwide drug distribution and increasing access to the anonymous and unregulated world of Internet pharmacies, what can be done to help patients avoid being in between a rock and a hard place when it comes to their health?
Some ideas I have include:
• creating a low cost/no cost drug program that segregates needy patients from private markets, with participation by both brand name and generic companies;
• identification and registration of legitimate drug wholesalers;
• banning Internet drug sales unless pharmacies are accredited by the National Association of Boards of Pharmacy;
• prohibiting drug importation;
• directing the Centers for Disease Control and Prevention to create aggressive public and provider education on counterfeit drugs;
• and,
• significantly increase increasing penalties for counterfeiters to fit the crime of cheating the hopes of the sick and vulnerable.
We have a ways to go before we get to these solutions because we need policymakers to think about both price and authenticity when they think of access. But I hope that as more people become aware of our vulnerabilities, the more they'll want policymakers to do something
about it.
In the meantime, consumers can protect themselves and their families by
• Subscribing to the Partnership for Safe Medicines free email alerts. (Link here)
• Downloading our simple SAFEDRUG guide. (Link here)
• If you have to buy drugs online, buying them only from verified online pharmacies. (Link here)
Click here and sign up for the SafeMeds email alerts of government counterfeit drug warnings. We'll talk about other tools in future discussions.
Straight from the Horse's Mouth
Yesterday's congressional hearing on the FDA's ability to guarantee the safety of our country's drug supply sounded another alarm that real consumer-protection measures need to be put in place that focus on patient safety.
Let's hope Congress doesn't hit the snooze button again.
It's been 9 years since the Government Accountability Office (GAO) last issued a report to Congress that highlighted the problems the FDA has had in its foreign drug inspection program.
But yesterday, Marcia Cross, director of healthcare for the GAO, painted an even more dismal picture. The GAO report and other testifying witnesses cited example after example of the holes in the FDA's efforts. Since an estimated 80% of the active pharmaceutical ingredients used to make drugs here are imported and another estimated 40% of finished drugs are made abroad, the GAO's findings are especially unsettling. Some highlights:
- Two-thirds of the foreign drug manufacturers subject to FDA inspection may never have been visited by FDA inspectors.
- Foreign drug manufacturers are only inspected once every 13 years - if ever.
- Due to scheduling pressures, foreign inspections can last only 2-3 days, whereas domestic inspections last a week to a month.
- The FDA's databases don't have accurate records as to what companies export drugs into the U.S. or whether they have been inspected.
- The FDA inspectors must provide months of notice to foreign firms that they will be inspected, compared with unannounced inspections in the U.S.
- FDA inspectors aren't provided with translators, leaving them to rely on English-speaking firm employees during their inspections.
- There is no requirement that the FDA conduct foreign inspections with any regularity, compared with every 2 years in the U.S.
- The estimated amount of FDA-responsible imports doubles every 5 years.
- The number of FDA inspectors will drop from 149 in 2002 to only 102 by 2008.
China is the primary country involved in drug manufacture. Rep. John Dingell (D-MI), chairman of the House panel looking into the matter, notes that China alone has 700 firms making drug products for the U.S., but the FDA has the resources to conduct only 20 inspections annually for this country.
But the unregulated Chinese firms are the source of much of the fake medicine throughout the world sold in markets and over the Internet. The World Health Organization estimates that 10% of all drugs are now counterfeit and 50% of drugs sold online are fake.
As supply chains become increasingly global, it's easier than ever for counterfeiters using these foreign materials of questionable quality to penetrate the U.S. market.
I'm encouraged by the congressional focus on this issue. But I hope another nine years doesn't pass before the FDA is given the resources to screen foreign-sourced drugs to ensure patient safety.
In the meantime, consumers must protect themselves and be aware of the risks they take in purchasing medicines from unknown and unverified sources and particularly questionable websites.
One way to do this is to click here and sign up for the SafeMeds email alerts of government counterfeit drug warnings. We'll talk about other tools in future discussions.