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Science | Is an expedited approval process putting unsafe medications on the market?

Issue: "Back to School," Sept. 6, 2014

One in three new medications available to consumers are later withdrawn from the market or given a black box warning due to safety risks. That represents a nearly 6 percent increase since Congress expedited the FDA approval process 22 years ago, according to a study published in the August issue of Health Affairs.

The Prescription Drug User Fee Act (PDUFA), passed by Congress in 1992 after heavy lobbying by the pharmaceutical industry, addressed growing concern about the time it took new medications to reach patients. PDUFA allows the FDA to collect fees from pharmaceutical companies to speed up the approval process. Average drug approval time has dropped by more than 50 percent, from 34 to 16 months, since the act was authorized. In 2012 President Obama signed into law the Food and Drug Administration Safety and Innovation Act, which includes reauthorization of PDUFA through September 2017. 

The study’s researchers admit the increased rate of medications being taken off the market or given a black box label does not prove the expedited process is the cause. Still, the statistics raise concern that some unsafe medications may be slipping through before side effects and risks have been thoroughly investigated.

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Lights out


Inevitable solar super storms could have catastrophic consequences on Earth, warns University of Bristol aerospace engineer Ashley Dale in this month’s issue of Physics World. Dale was part of a team of space experts who examined the potential damage such an event could cause. The team’s report, SolarMax, called on policymakers to fund research and subsequent actions to protect society “as we know it.”

The sun goes through an 11-year cycle culminating with the SolarMax, a phenomenon in which the magnetic poles flip. It is during this time that gigantic explosions—solar flares—are most apt to occur. These violent events can disrupt Earth’s magnetic field and play havoc with all forms of technology. For example, power surges could blow up transformers, cutting off electricity for entire nations or even continents for weeks, causing disruptions in food and water supply, sewage removal, medical care, transportation, heating, etc. The result could be economic devastation and a global crisis, the scientists warn. It is estimated that even a typical solar storm can cost as high as $3 billion to $6 billion in total losses.

The strongest solar storm ever recorded hit Earth in 1859, damaging telegraph lines and railroads and igniting auroras visible as far south as Cuba and Hawaii. Another solar storm in 1989 knocked out the entire Quebec power grid leaving 6 million people without electricity for over nine hours and costing an estimated $4 billion to $10 billion.

NASA scientists said a powerful solar flare barely missed Earth in 2012. They estimate there is a 12 percent chance that another solar storm, at least as powerful as the one of 1859, will hit Earth in the next 10 years. —J.B.

System upgrades


Satellites orbiting Earth can function only as long as their fuel supplies last. NASA is developing a robotic fueling station that can add years of useful life to spacecraft by going to a satellite and refueling, repairing, or relocating it in orbit.

Approximately 1,000 spacecraft orbit Earth. These include the international space station, weather satellites that predict storms and assist with search and rescue missions, and scientific spacecraft that study the stars. 

NASA’s Bob Granath said NASA hopes to expand options for satellite operators who face tougher economic demands and aging fleets. —J.B.

Julie Borg
Julie Borg

Julie is a clinical psychologist and writer who lives in Dayton, Ohio. She is a graduate of the WORLD Journalism Institute's mid-career course.


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