Topic: Drug Safety

Pew Comment Letter to the Senate HELP Committee on Compounding Legislation

Pew sent a comment letter to the Senate Committee on Health, Education, Labor and Pensions on the Pharmaceutical Compounding Quality and Accountability Act. This bill takes steps toward clarifying state and federal oversight of compounding, including an important increase in FDA supervision of certain activities—specifically, the compounding of sterile medicines that are shipped interstate.

''Lawmaker Would Give FDA More Oversight of Drug Compounding''

Representative Edward Markey, a Democrat from Massachusetts, on Thursday became the latest lawmaker to propose legislation that would give the U.S. Food and Drug Administration greater regulatory authority over drug compounding.

Pew Testimony: Examining Drug Compounding

On Thursday, May 23, the House Energy & Commerce Subcommittee on Health held a hearing, entitled "Examining Drug Compounding." Gabrielle Cosel, a drug safety expert, testified on the need to clarify oversight of compounding pharmacies on the state and federal level.

''Senate Panel Approves Tighter Oversight of Compounding Pharmacies, but Bill is Under Fire''

Public health and consumer advocacy groups are attacking Senate legislation designed to tighten oversight of specialized pharmacies such as the one at the center of this past fall’s deadly meningitis outbreak, saying it does not adequately address health risks.

''Rep. Bob Latta's Plan to Thwart Fake Drugs Passes House of Representatives Committee''

An Ohio legislator’s plan to establish a nationwide prescription drug tracking system to protect patients from fake drugs was approved by the House Commerce Committee.

''Drug Manufacturer Agrees to $500 Million Penalty''

''A subsidiary of India's largest pharmaceutical company has agreed to pay a record $500 million in fines and penalties for selling adulterated drugs and lying to federal regulators in a case that is part of an ongoing crackdown on the quality of generic drugs flowing into the U.S."

''Community Pharmacies Will Now Back Supply Chain Legislation''

"As differing bills for securing the pharmaceutical supply chain wind their way through the US House and Senate, a key hurdle to passing legislation may have just been cleared. Earlier this week, the National Community Pharmacists Association – which is a member of an influential industry coalition that has been floating its own proposals – is now willing to back either bill."

''Senators Say They Are Close to Writing a Final Pharmacy Compounding Bill''

"U.S. senators considering fundamental changes to how the practice of pharmacy compounding is regulated heard almost unanimous support for reform at a Washington committee hearing Thursday."

''Senate Moves Closer to Law to Prevent More Pharmacy Outbreaks''

"At least 67 people have died in 20 outbreaks caused by contaminated drugs since 2001, experts told a Senate hearing Thursday. The Food and Drug Administration says there have likely been more cases than that, but they have no way of telling now."

''State Pharmacy Boards Back More FDA Oversight''

"State pharmacy officials on Thursday threw their support behind a proposal giving the Food and Drug Administration authority over large compounding pharmacies, in an effort to head off more outbreaks tied to contaminated medications."

''The Senate Aims to Clean Up Compounding Pharmacies''

When a doctor sticks a needle in you, you expect that the drugs it carries won’t be tainted. But, possibly owing to a strange gray area in federal law, thousands of patients last October got injections for back pain that contained highly dangerous fungal meningitis, and dozens of them died. Members of the Senate Health, Education, Labor and Pensions Committee are now seeking to fix the government’s oversight of the obscure world of compounding pharmacies. The reforms they want are overdue.

Pew Testimony to House Energy and Commerce Subcommittee on Health Regarding Drug Supply Chain

The House Energy & Commerce Subcommittee on Health will hold a hearing on April 25 entitled "Securing Our Nation’s Prescription Drug Supply Chain." Allan Coukell, a pharmacist and drug safety expert, will testify on the need to establish a national system to track and authenticate medicine. The principles outlined in his prepared testimony are supported by other stakeholders in statements from consumer, patient, public health, and industry groups.

''Crackdown Needed on Specialty Pharmacies''

"The deaths and illnesses linked last fall to a New England pharmacy operating in the regulatory shadows as a cut-rate drug manufacturer is one of the biggest pharmaceutical public health disasters in American history."

''Generic Drug Maker Stops Making Cholesterol Pill''

Ranbaxy Pharmaceuticals, the largest producer of the generic version of Lipitor, has halted all production of the drug until it can figure out why glass particles may have ended up in pills that were distributed to the public, the Food and Drug Administration announced Thursday.

Expert Profile: Gabrielle Cosel

Gabrielle Cosel, Project Manager, Drug Supply Safety

Prescription Drug Monitoring Programs: An Assessment of the Evidence for Best Practices

A PDMP is a statewide electronic database that gathers information from pharmacies on dispensed prescriptions for controlled substances. This white paper describes what is known about PDMP best practices and documents the extent to which these practices have been implemented.

As Prescription Painkiller Overdoses Mount, Researchers Outline Effective Approaches to Curb Epidemic

Prescription painkillers are responsible for more fatal overdoses in the United States than heroin and cocaine combined. And while most states have programs to curb abuse and addiction, a new report shows that many states do not fully analyze the data they collect.

Testimony of Allan Coukell Before the Committee on Commerce, Science and Transportation

Pew's Allan Coukell submitted a statement of record to the Congressional Committee on Commerce, Science and Transportation regarding concerns with the pharmaceutical supply chain. The focus of Coukell's testimony was the drug distribution system – the weaknesses in the system and the risks of counterfeit and stolen drugs.

Pew Applauds Enactment of User Fee Legislation, Urges Its Swift Implementation

President Barack Obama today signed into law the Food and Drug Administration Safety and Innovation Act, which supports the U.S. Food and Drug Administration’s drug and device reviews and includes other measures to benefit patients.

''Drug, device reform gets bipartisan push''

"The U.S. Supreme Court's eagerly awaited Affordable Care Act ruling unfortunately overshadowed the unusually bipartisan work underway at the U.S. Capitol last week, where Congress finalized sweeping legislation crammed with smaller-scale but still vital health reforms."

''Congress poised to pass safety-focused FDA bill''

"A bill designed to beef up the safety of the nation's prescription drug supply is poised to pass Congress, but without a tracking system that public health advocates say is critical to weeding out counterfeit pharmaceuticals."

Pew Applauds Passage of Bipartisan User Fee Legislation by U.S. House of Representatives

The U.S. House of Representatives today passed bipartisan legislation to ensure that the U.S. Food and Drug Administration (FDA) has the funds it needs to approve products that improve health and protect consumers from unnecessary risks.

''Senate bill aims to increase drug import safety''

"U.S. regulators would inspect more drug manufacturing facilities in China, India and other foreign countries as part of legislation approved Thursday that aims to step up oversight of the nation's imported pharmaceutical supply."

Heparin: A Wake-Up Call on Risks to the U.S. Drug Supply

While the vast majority of drugs in American pharmacies and medicine cabinets are safe, globalization and reliance on outsourced manufacturing creates new risks, including deliberate tampering with ingredients and inadequate quality controls in plants that operate largely outside the scrutiny of the FDA.

Case Studies: How Unsafe Drugs Can Reach Patients

The following case studies illustrate breaches to the pharmaceutical supply chain—the route a drug travels from its raw material origins to the delivery of a finished medicine. These examples, all of which are discussed in Pew Health Group’s report After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs, demonstrate the different ways in which contaminated, fake, or otherwise unsafe medicine can reach patients, and underscore the need for reform.

''FDA Alerts Doctors on Fakes''

"The Food and Drug Administration warned more than 50 doctors and medical practices in the U.S. that they may have bought a fake version of the cancer drug Avastin ... "

Testimony before the Committee on Energy and Commerce Subcommittee on Health

U.S. House of Representatives PDF Download Since 1992, user fee agreements have given FDA significant and sustained resources that allow the agency to review new products quickly. In fact, preliminary findings of a study that Pew has funded show that FDA reviews new drugs faster than its cou

Reviving the Pipeline of Life-Saving Antibiotics

Antibiotic-resistant infections are a growing public health threat. At the same time, antibiotic innovation is waning. Pew, the IIDSA and PhRMA hosted a one-day conference, Reviving the Pipeline of Life-Saving Antibiotics: Exploring Solutions to Spur Innovation on September 22, 2011, exploring ways to overcome the challenges that hinder the development of new antibiotics.

Testimony before the Senate Committee on Health, Education, Labor and Pensions

Allan Coukell, Director of Medical Programs, Pew Health Group: Chairman Harkin, Ranking Member Enzi, and members of this committee, thank you for the opportunity to testify about the importance of the user fee agreement legislation to patients.

''Editorial: Crack down on counterfeit drugs''

Strong, national 'track and trace' system is overdue.

''Fake Avastin shows very little protects drug supply''

"As drug counterfeiters step up their sales of bogus medicines, global health regulators have few protections in place to prevent them from reaching patients, and new laws aimed at addressing the problem could be years away ... "

''Industry Alliance Floats Lot-Level Drug Tracing System in Legislative Proposal''

"An industry coalition forming consensus around drug track and trace systems is floating a legislative proposal that would trace drugs on the lot level while also requiring product level identification ... "

Testimony of Allan Coukell on the Lack of a National Pharmaceutical Tracking System

On March 8, 2012, Pew Health Group’s Director of Medical Programs Allan Coukell testified before the Energy and Commerce Committee’s Subcommittee on Health regarding the drug distribution system – the risks of counterfeit and stolen drugs, and the pragmatic steps Congress can take to reduce those risks.

Testimony before the House Committee on Energy and Commerce, Subcommittee on Health

Allan Coukell, Director of Medical Programs, and Sharon Ladin, Director of the Antibiotics and Innovation Project, testify before the House Committee on Energy and Commerce, Subcommittee on Health on stimulating the development of new antibiotics urgently needed to fight serious and life-threatening bacterial infections.

''Fakes Infiltrate Injectable Drugs''

"News that a counterfeit version of the cancer drug Avastin was found in the U.S. highlights a rising threat: fakes of costly injectable therapies, rather than simple pills, such as Viagra."

''System to catch fake drugs has idled for years''

"The news this week that a fake version of the cancer medicine Avastin has made its way into the United States highlights a longtime concern: There are few safeguards to make sure fake drugs can be spotted before they make it to your doctor’s office."

Pew Urges Congress to Pass Medical Device User Fee Act and Improve Marketplace Monitoring

We applaud the FDA and the medical device industry for reaching an agreement that will spur the innovation of new therapies for improving health and saving lives.

Testimony of Allan Coukell before the Committee on Energy and Commerce, Subcommittee on Health, United States House of Representatives

"Pew has been working to identify the risks to the drug supply and advance pragmatic solutions. In July of 2011, we released a report entitled “After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs."

''FDA and drug industry agree on user-fee proposal for generics''

"The Food and Drug Administration would collect hundreds of millions of dollars in new fees from pharmaceutical companies to help speed up the review of generic drugs, under an agreement with the industry released by the agency on Friday."

''FDA unveils user fee program for generic drugs''

"The Food and Drug Administration would collect hundreds of millions of dollars in new fees from pharmaceutical companies to help speed up the review of generic drugs ... "

Pew Commends Pharmaceutical User Fee Agreements, Urges Swift Action by FDA and Medical Device Industry

We commend the FDA and the pharmaceutical industry for working together on agreements that support the agency’s review activities. Under PDUFA, the FDA has reduced the time it takes to approve new drugs.

A Look Into The Pharmaceutical Supply Chain With Examples Of Vulnerabilities

Drug manufacturers and distributors work together in a robust system to deliver high quality products, but our pharmaceutical supply has become increasingly complex in recent years. Medicines originate in factories all over the world,

Allan Coukell

Allan Coukell oversees medical programs, including the Pew Prescription Project, the Drug Safety Project, the Antibiotics and Innovation Project, the Medical Device Safety project and the FDA Modernization Initiative, as well as other activities related to medical products and services.

Gabrielle Cosel

As project manager of the Drug Safety Project, Gabrielle Cosel works on federal initiatives to ensure the safety and oversight of the U.S. pharmaceutical supply chain.

''FDA Goes Overseas to Monitor Imports''

"As American companies seek a more cost-effective environment and larger pools of patients, weighing the clinical data gathered at trials outside of the United States is one example of how globalization has affected the responsibilities of the Food and
Drug Administration."

''Safer drug supply requires update to our regulation''

"Americans might expect their prescription drugs to be “Made in the U.S.A.,” but just like clothing or electronics, their medicine is increasingly produced in developing nations. In fact, according to a U.S. Government Accountability Office (GAO) report, at least 80 percent of the ingredients in U.S. drugs now originate overseas. This could be real cause for concern."

''Safety of Foreign-Made Prescription Drugs''

"Allan Coukell talked about the Governmental Accountability Office (GAO) report on the make-up of prescription drugs, and he responded to telephone calls and electronic communications."

Testimony of Allan Coukell before the Committee on Health Education Labor and Pensions, United States Senate

"A major focus of the Pew Health Group is identifying ways to improve the safety of the U.S. pharmaceutical supply chain. In July of this year, we released a report entitled 'After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs.'"

''As Production Goes Global, Drug Supply Faces Greater Risks to Safety, Quality''

"The adulteration, estimated to have netted the individuals responsible for adding the chemical between $1 million and $3 million, led to hundreds of adverse events, including at least 3 deaths, according to a recent report from the Pew Health Group."

Distribution System OK, But it Can be Exploited

Drug distribution may involve many trading partners, which can make it difficult to determine the products’ sources or authenticity. Medicines are often bought and sold across state lines; moved in whole or partial lots; and repackaged or relabeled. These practices may be appropriate, but bad actors also may exploit vulnerabilities in this system.

''The Drug Supply Chain''

Allan Coukell, director of Medical Programs at Pew Health Group, appears on the Kojo Nnamdi Show as they explore the globalization of the drug industry and what it means for the quality and safety of our prescription drugs.

''Nanoscale Encryption: The Solution to Counterfeit Drugs?''

"Counterfeit and stolen drugs endanger patients, undermine public health and cost billions. Are encrypted pills the answer?"

A Look Into U.S. Drug Supply Safety

An overview of the complex pharmaceutical supply chain from manufacturing through distribution of the finished drug, and advances proposed policy solutions to help reduce the risks of counterfeit, adulterated and substandard drugs.

''New drug regulator asks Congress for more power''

"Drug companies should take more responsibility for the safety of ingredients sourced overseas, and Congress should make them if they do not, according to the new U.S. drug regulator for import safety."

''PEW Recommends Steps to Secure the Supply Chain''

"The pharmaceutical industry and US regulatory bodies have not responded adequately to the increasing level of outsourced manufacturing in countries such as China and India, according to a new white paper by the PEW Health Group."

''Pharmaceuticals: Report recommends measures to mitigate risk in a global supply chain''

"Keeping the public safe in an age of global pharmaceutical sourcing requires improved safety testing standards, greater industry oversight of contract manufacturers and suppliers, and expanded enforcement authority for FDA backed by stronger penalties and clearer accountability, says a new report from the Pew Charitable Trusts."

''How Safe Are the Drugs in Your Medicine Cabinet?''

"Do you want your new prescription drugs to be made under last century's oversight? Like it or not, that's likely what you're getting -- or worse -- according to recent research from the Pew Health Group. Increasingly, Americans' medicines are made overseas in place where the oversight isn't up to U.S. standards, according to the white paper, After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs."

''White paper lays out reform strategy for US medicines supply chain''

"US think tank Pew Health Group has called for a wide-ranging overhaul of the US pharmaceutical distribution system, including the introduction of a federal serialisation system, in order to protect consumers from unsafe medicines."

''Pew track-trace call highlights congressional dallying''

"The FDA should have the power to mandate recalls, subpoena witnesses and documents, and destroy at the border any products that pose a public safety risk. So says Pew Health Group in a just published report, After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs."

''Report Identifies Serious Gaps in Drug Safety Oversight''

"Americans' medicines are increasingly manufactured in developing countries, where oversight is lower than in the United States, according to a new white paper by the Pew Health Group."

''FDA calls for more congressional oversight on global drug economy''

"The Food and Drug Administration called on Congress Tuesday to make the laws that govern the global prescription drug economy stronger. In a report released Tuesday by the Pew Health Group, researchers looked at the globalization of pharmaceutical production and the domestic distribution of prescription drug, with an eye on how the FDA can more effectively regulate both."

''FDA must be empowered to oversee supply chain; report''

"Congress must grant the FDA additional powers to bring oversight of manufacturing inline with shifts in production practices, according to a report. In a report titled After Heparin, Pew Health Group breaks down current weaknesses in the supply chain and proposes fixes. Empowering the US Food and Drug Administration (FDA) is one of the main themes of the Pew report."

''Pew Study Finds Gaps in FDA Oversight of Imported Drugs''

"The Food and Drug Administration needs much more power to protect the U.S. supply of drugs as more and more are made in other countries, the Pew Health Group reported on Tuesday."

''Globalised supply chains threaten drug safety''

"The globalisation of manufacturing and use of increasingly complex supply chains in the drugs and chemicals industries leaves millions at risk of counterfeit, adulterated and substandard pharmaceuticals, a new report has claimed."

''Consumer Confidential: Outsourced meds, Social Security tool, Casey Anthony hoax''

"Where does our medicine come from? Increasingly, the answer is overseas, where safety standards can be lower."

After Heparin

This report provides an overview of the complex pharmaceutical supply chain from manufacturing through distribution of the finished drug, and advances proposed policy solutions to help reduce the risks of counterfeit, adulterated and substandard drugs.

Read two fact sheets describing the heparin adulteration and other examples of breaches to the U.S. drug supply.

View an interactive graphic presenting an overview of today's globalized pharmaceutical supply chain and its vulnerabilities.

Pew Finds Serious Gaps in Oversight of U.S. Drug Safety

Americans’ medicines are increasingly manufactured in developing countries, where oversight is lower than in the U.S., according to a new white paper by the Pew Health Group. The U.S. Food and Drug Administration (FDA) estimates 40 percent of finished drugs and 80 percent of active ingredients and bulk chemicals used in U.S. drugs come from overseas.

''China Illustrates Challenges for ‘Global’ FDA''

"Faced with a chronic shortage of staff around the world and a lack of enforcement authority in foreign countries, the FDA has come up with a plan to transform itself into a “truly global agency,” according to a report (pdf) on product safety and quality it released on Monday."

''FDA Lays Out Global Strategy to Monitor for Dangerous Foods, Drugs''

"In an unusual special report Monday, the Food and Drug Administration laid out a strategy it hopes will help it do a better job of policing America's food and drug supply. Called the Pathway to Global Product Safety and Quality, the 36-page document outlines a plan to work globally to track the international movement of food and drugs."

''Shock To The System''

"In the wake of the heparin scandal, FDA admitted that rampant globalization in drug manufacturing has outstripped the agency’s resources for inspecting foreign facilities."

''FDA Opened 72 New Counterfeit Cases in 2010--a New Record''

"During a presentation at a meeting organized by the Pew Prescription Project (Washington, DC., March 7-8), deputy administrator Dr. Ilisa Bernstein noted that 72 cases had been opened by FDA’s Office of Criminal Investigations in FY 2010 (which ended Sept. 30). That’s up nearly 11% from the year before, which was also an up year."

Testimony before the Committee on Energy on Commerce, Subcommittee on Oversight and Investigations, United States House of Representatives

"Chairman Stearns, Ranking Member DeGette, and members of the Oversight and Investigations Subcommittee, thank you for the opportunity to submit testimony about the essential steps Congress must take to protect Americans and ensure the integrity of our drug supply..."

Consumer and Drug Industry Representatives Back New Fees to Cover Inspections

Allan Coukell, director of the Medical Safety Division of the Pew Health Group, issued the following statement today, commenting on a March 14-15 conference, "After Heparin: A Roundtable on Ensuring the Safety of the U.S. Drug Supply," in which industry and consumer experts called for changes to address the risk of counterfeit and substandard medicine

After Heparin: A Roundtable on Ensuring the Safety of the U.S. Drug Supply

The Pew Charitable Trusts hosted a roundtable discussion addressing the safety of the U.S. drug supply. Expert presentations were part of a larger conversation on the issues and solutions raised in a draft white paper entitled, After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs.

''FDA: Another tainted drug crisis seems inevitable''

"A senior Food and Drug Administration regulator warned that another public health crisis may be inevitable because the agency can't guarantee the safety of many drugs and food products manufactured overseas."

''House Investigates Heparin Crisis''

"The House Energy and Commerce Committee is conducting a formal investigation into the contaminated-heparin crisis of 2008, saying it wants regulators to figure out who was responsible for adulteration linked to 81 U.S. deaths."

''Top-name drug recalls a bitter pill for consumers''

"Industry officials and experts say the rise of well-known product names on major recalls is partly due to enhanced regulatory scrutiny."

''FDA relies too much on tipoffs, not enough on drug checks''

"A drug-company whistle-blower last month pocketed $96 million -- her share of the money Medicare and Medicaid paid for tainted drugs. The fee is way too high -- employees will drop a dime for far less."

''Drugs, Supplements come to U.S. from China largely unregulated''

"Federal regulators have inspected only a fraction of the hundreds of Chinese factories making prescription drugs for the U.S. market, a new report from the Government Accountability Office says."

''Delhi's Fake Drug Whitewash''

Counterfeit drug expert Roger Bate said that a report issued by India's Central Drug Standard Control Organization this summer indicating that less than .1% of drugs sampled in the country were fakes is flawed and contradicts well-established findings by the government and scholars that suggest the number of counterfeits is much higher.

''The Drug Safety and Accountability Act is overdue''

"The Drug Safety and Accountability Act, a bill filed today by Senator Michael Bennet (D-Colorado) is long overdue in protecting American citizens from unsafe drugs."

Drug Safety and Accountability Act of 2010

The Drug Safety and Accountability Act of 2010 (S.3690) seeks to strengthen industry standards to ensure the quality and safety of drugs made for the U.S. market, and to improve the U.S. Food and Drug Administration’s (FDA) oversight abilities through modernized information systems and new authorities, such as the power to order a drug recall.

''Voters trust drugs made in USA, but few are''

"More than three out of four voters are confident that prescription drugs made in the USA are free from contamination, while fewer than one in 10 feel confident about medications made in India or China, according to a poll released today by the Pew Charitable Trust's Prescription Project."

Consumer and Manufacturing Groups Back Bill to Protect U.S. Drug Supply after a Year of Record Recalls

The Pew Prescription Project, joined by major consumer, physician and chemical manufacturer groups, today announced support for a new bill that would give the FDA much-needed authorities to better protect pharmaceutical supply chains.

Americans' Attitudes on Prescription Drug Safety

This issue brief presents key findings from a nationwide survey about the safety of the U.S. drug supply among voters conducted March 29 –April 1, 2010 for the Pew Prescription Project by Hart Research Associates Public Opinion Strategies.

''China Never Investigated Tainted Heparin, Says Probe''

"The Chinese government didn't pursue an investigation into contaminated heparin sent to the U.S. in 2007 and 2008, despite repeated requests from the U.S. for help, according to a congressional probe."

''FDA to Propose Tougher Rules for Outsourcing Drug Manufacturing''

"The Food and Drug Administration said Monday it will propose stronger regulations for pharmaceutical companies that outsource manufacturing, putting more responsibility on the companies to ensure the purity and safety of products made by contractors."

''Maker of children's drugs accused of hiding Motrin recall from public''

"The company at the center of a massive recall of children's Tylenol and other popular over-the-counter products tried to perform a "phantom recall" of defective Motrin by sending contractors around the country to buy up the medicine from stores without alerting regulators or the public, according to the chairman of a Congressional committee investigating the company."

Pew Statement on Energy and Commerce Drug Safety Hearing

"Two years after dozens of Americans lost their lives to contaminated heparin, we are still unable to protect U.S. consumers from many of the risks of pharmaceuticals manufactured in foreign factories. It is time for Congress to take action to better protect health."

Pew Statement On House Hearing Regarding FDA Drug Safety Reforms

Allan Coukell, director of the Pew Prescription Project, issued the following statement today, commenting on a hearing at the U.S. House Energy and Commerce Subcommittee on Health, where Food and Drug Administration (FDA) Principal Deputy Commissioner Joshua M. Sharfstein is expected to present testimony regarding the agency’s ability to protect Americans from unsafe drugs made overseas.

Statement on Congressional Hearing Regarding FDA Drug Safety Reforms

Allan Coukell, director of the Pew Prescription Project, issued the following statement today, commenting on a hearing at the U.S. House Energy and Commerce Subcommittee on Health, where Food and Drug Administration (FDA) Principal Deputy Commissioner Joshua M. Sharfstein is expected to present testimony regarding the agency's ability to protect Americans from unsafe drugs made overseas.

Bill Comparison - Regulation of Overseas Drug Manufacturing

This issue brief from the Pew Prescription Project outlines the differences between bills from the U.S. House of Representatives and the U.S. Senate regarding regulation of overseas drug manufacturing.

Bill Summary - Counterfeit Drug Enforcement Act of 2009

This issue brief is a summary of H.R. 2726 - The Counterfeit Drug Enforcement Act of 2009, also known as the Tim Fagan Law.

FDA Globalization Act of 2009: Drug Safety Provisions

The Food and Drug Administration Globalization Act of 2009 (H.R.759) seeks to secure the safety of imported prescription drugs and active pharmaceutical ingredients through greater FDA authority and manufacturer responsibility, and increased inspections of prescription drug and active pharmaceutical ingredient manufacturing sites abroad.

Testimony of Allan Coukell, Director of the Pew Prescription Project, on Protecting Consumers from Adulterated Drugs

Protecting consumers against the risk of adulterated products is, of course, the original mission of the FDA. Today, the vast majority of pharmaceutical products sold in the United States today are not adulterated, but an increasingly complex supply chain creates new challenges and new risks – as recent events demonstrate.