News Scan for Mar 31, 2017

Antibiotic tax credit
;
Zika vaccine trial advances
;
FDA shutters nut butter maker

Legislation calls for tax credits for new antibiotics, diagnostic tests

US lawmakers today introduced legislation that would provide a tax credit for new antibiotics and diagnostic tests.

The Reinvigorating Antibiotic and Diagnostic Innovation (READI) Act, H.R. 1840, would amend the Internal Revenue Code of 1986 to provide a tax credit for 50% of the clinical testing expenses for new antibiotics that treat a serious or life-threating infections and new rapid diagnostic tests. The bill, introduced by US Representatives Mike Thompson (D-CA) and Erik Paulsen (R-MN), is modeled on the orphan drug tax credit, meant to provide incentives to pharmaceutical companies to invest in treatments for rare disease.

The idea is to encourage drug makers to develop new antibiotics, which are expensive to develop and don't produce the type of financial returns that drugs for chronic conditions do. There are currently only 40 antibiotics in the development pipeline, and 70% of those are in already-existing classes.

"Most pharmaceutical companies have retreated from antibiotic research and development because antibiotics are difficult and costly to develop and fail to provide a profit," Henry Chambers, MD, chief of the division of infectious diseases at San Francisco General Hospital, said in a press release from the Infectious Diseases Society of America (IDSA). "The READI Act will provide a much-needed incentive for companies to develop the new antibiotics that patients so desperately need."

IDSA President William Powderly, MD, added that new rapid diagnostic tests are equally necessary. "Without rapid tests, we must often treat empirically—before we know exactly what type of infection a patient has—which can lead to antibiotic overuse," he said.

IDSA was one of 41 medical organizations, pharmaceutical companies, and diagnostics companies that signed a letter of support for the legislation.
Mar 31 IDSA press release

 

First phase 2 Zika vaccine trial begins

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), launched phase 2 of their multi-site two-part DNA Zika vaccine trial, VRC 705.

"We are pleased to have advanced rapidly one of NIAID's experimental Zika vaccines into this next stage of testing in volunteers. We expect this study will yield valuable insight into the vaccine's safety and ability to prevent disease caused by Zika infection," said NIAID Director Anthony S. Fauci, MD. "This trial marks a significant milestone in our efforts to develop countermeasures for a pandemic in progress."

NIAID aims to enroll 2,490 healthy participants in areas with active or potentially active mosquito-transmitted Zika zones, including the United States and Puerto Rico, Brazil, Peru, Costa Rica, Panama and Mexico. This is the first Zika vaccine to make it to the second phase of human trials, which will gather more safety and immune response data, focusing on if the vaccine is effective when recipients are naturally exposed to Zika.

The vaccine uses a small circular piece of DNA called a plasmid that contains proteins found in the Zika virus. When injected intramuscularly, the plasmid triggers an immune response to the mosquito-borne virus.

Participants in the first part of the trial, designed to determine the optimal dose and injection site, will follow participants for 32 weeks. The second part, designed to assess protection after natural exposure to the virus, will follow participants for 2 years.
Mar 31 NIH press release

 

Soy nut butter operations halt in wake of E Coli outbreak

The Food and Drug Administration (FDA) has suspended operations of Dixie Dew Products of Erlanger, Ky., the plant that produced the I.M. Healthy SoyNut Butter implicated in a multistate Escherichia coli O157:H7 outbreak. The operations were stopped on Mar 28, the agency said yesterday.

The FDA inspected the facility between Mar 3 and Mar 15 and determined there were insanitary conditions at the plant producing the soy nut paste used in the butter and other products. According to the FDA, "The Suspension Order applies to the entire facility. While the order is in effect, no food product may leave the facility for sale or distribution." The suspension is indefinite.

According to Food Safety News, FDA records show that Dixie Dew Products violated food safety standards for at least 15 years. Listed in the FDA's report are accounts of inspectors finding an infestation of flies, a leaking roof, and dirty food production tools at the plant.

As of yesterday, a total of 29 people in 12 states became ill after eating contaminated nut butter. Nine of those patients have suffered from hemolytic uremic syndrome (HUS), but there have been no deaths.
Mar 31 FDA notice
Mar 31 Food Safety News
story

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