Featured Issue Briefs

The Battle on the Home Front: Jonathan Gadsden's Story

The Battle on the Home Front: Jonathan Gadsden's Story

Marine Lance Corporal's story reflects the growing need for new antibiotics that can treat dangerous diseases, against which most drugs are useless. Read More

Facilitating Medical Device Innovation: De Novo Reform

Facilitating Medical Device Innovation: De Novo Reform

The de novo process -- which requests lower-risk reclassification of medical devices and entry into the marketplace -- as it exists now is not achieving its purpose and has instead added unnecessary and time-consuming requirements. Read More

Food Products Recalled by FDA

Food Products Recalled by FDA

Since President Obama signed the FDA Food Safety Modernization Act into law, at least 149 FDA-regulated food products have been recalled due to potential pathogenic contamination. Read More

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Apr 9, 2014

The Super Bugs Causing Unmet Need and the Drugs to Fight Them

Testing new antibiotics to treat highly resistant bacterial infections is especially difficult, since only a small number of patients contract such infections or meet the requirements to participate in clinical trials. Following are examples of hard-to-treat pathogens that present the greatest unmet needs today, and the types of drugs that are most likely to address them.

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Antibiotic Innovation

Feb 27, 2014

Testimony of Elizabeth Jungman on Counterfeit Medicines

The House Energy and Commerce Subcommittee on Oversight and Investigation held a hearing on Feb 16 entitled "Counterfeit Drugs: Fighting Illegal Supply Chains." Elizabeth Jungman, director of drug safety and innovation testified on counterfeit drugs the importance that newly passed Drug Quality and Security Act will have on the safety of the U.S. pharmaceutical supply chain.

 

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Drug Manufacturing and Distribution, Drug Safety

Feb 26, 2014

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.

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Drug Manufacturing and Distribution, Drug Safety

Feb 11, 2014

New FDA Policies on Antibiotics Use in Food Animal Production

Surveys of the animal production industry by the U.S. Department of Agriculture demonstrate that many farms and ranches administer antibiotics to healthy animals at low doses to offset overcrowding and poor sanitation and to accelerate livestock growth—practices that the medical and public health communities document as a significant factor in human antibiotic resistance. In 2013, FDA took steps to address these concerns.

 

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Antibiotics in Food Animal Production

Feb 3, 2014

Pew Comments to FDA Draft Guidance on 503A

On January 31, Pew submitted comments to the U.S. Food and Drug Administration in response to draft guidance on the implementation of Title I of the Drug Quality and Security Act and addressed five topics: anticipatory and office stock compounding; quality standards; FDA / state coordination; MOUs to address inordinate interstate shipment of compounded drugs; use of bulk drug substances.

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Drug Safety

Dec 12, 2013

Letter from Pew Thanking Representatives Gingrey and Green for Leadership on New Antibiotics Legislation

Representatives Phil Gingrey (R-GA) and Gene Green (D-TX) introduced legislation intended to bring antibiotics to patients with few other treatment options. In a letter, Pew called the bill, named the Antibiotic Development to Advance Patient Treatment (ADAPT) Act, “a welcome step towards establishing a new regulatory pathway to bring desperately-needed antibiotics to the patients who need them the most.” More

Antibiotic Innovation

Oct 30, 2013

Pew Urges Improved Antibiotic Data Reporting

In comments to the U.S. Food and Drug Administration, Pew asked the agency to improve the way it reports annual sales of antibiotics for use in food animal production. Chief among its recommendations, Pew urged the FDA to amend the definition of “therapeutic” antibiotic use to more clearly exclude inappropriate uses for so-called “disease prevention” purposes that, in practice, are similar or identical to growth promotion.

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Antibiotics in Food Animal Production

Sep 10, 2013

Letter from the Healthcare Transformation Group on UDI Rule Delay

Five prominent health systems, known as The Healthcare Transformation Group (HTG), sent a letter to the White House’s Office of Management and Budget urging a prompt review of the unique device identifier (UDI) rule. Like Pew, HTG believes further delay of the rule’s release will impair the Food and Drug Administration’s ability to conduct important surveillance of medical devices.

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Drugs and Devices at the FDA

Aug 14, 2013

Workshop on Potential Conflicts of Interest in GRAS Additive Decisions

On Wednesday, August 7, 2013, the Food Additives Project at The Pew Charitable Trusts hosted a multi-stakeholder workshop that discussed approaches to managing these conflicts of interest. The workshop was meant to explain the concerns that have been raised regarding the potential for COI in GRAS selfdeterminations, and identify and discuss approaches to resolving those concerns.

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Food Additives

Jul 31, 2013

Pew Applauds Senators Bennet and Hatch for LPAD Leadership

Pew and the Infectious Diseases Society of America applaud Senators Michael Bennet (D-CO) and Orrin Hatch (R-UT) for their leadership in supporting the creation of the Limited Population Antibacterial Drug (LPAD) pathway. Once put in place, LPAD would expedite patient access to critically-needed antibiotics to treat serious or life-threatening infections for which there are currently inadequate treatment options.

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Antibiotic Innovation