In July 2015 a bill called “21st Century Cures” was overwhelmingly passed by the
US House of Representatives.
The legislation would increase funding towards the federal drug-approval process, and help
expedite the certification of new medicines.
While this is encouraging for pharmaceutical companies, some are worried that Americans
will be more exposed to dangerous drugs.
So, how does a drug get approved for the the US market?
Well, the Food and Drug Administration is one of the world’s strictest regulatory
agencies.
Both the testing and manufacturing phases are closely monitored.
To get a new drug certified, pharmaceutical companies are responsible for testing it themselves.
But they follow strict guidelines dictated by the FDA’s Center for Drug Evaluation
and Research.
This agency tells them how many and what kind of trials are necessary.
Then experts, including physicians, chemists, and statisticians, review the trial data,
and decide whether the drug should be certified or not.
From 2004 to 2012, the CDER approved an average of 26 drugs per year.
In the past decade, about 80% of drug ingredients, and 40% of prescription drugs sold in the
US were foreign-made.
In order to handle increased globalization, in 2011, the “FDA Food Safety Modernization
Act” was established.
This allowed the agency to create additional foreign offices to inspect imported food and
drugs.
Additionally, modern surveillance and digital data compiling systems have helped the FDA
pinpoint any security risks in the the timeline of drug manufacturing.
In 2015, the agency banned imports from a large Indian drug company after inspections
revealed that quality standards were not met.
The FDA also works closely with international trade organizations to ensure the security
of food and drug transport.
If anything goes wrong with a new drug, the FDA plays an important role in penalizing
the responsible drug company - usually with large fines.
Individuals may also file lawsuits if they were harmed by a new drug.
In 2012, as a result of incorrect health ratings on some newly developed medicines, healthcare
giant GlaxoSmithKline paid $3 billion dollars in criminal and civil charges.
But despite major incentives and regulations which promote the manufacturing of safe drugs,
the system isn’t perfect.
The FDA has drawn criticism for allowing many foreign clinical trials, which may involve
adults and children in poorer nations being used as guinea pigs.
Although GlaxoSmithKline has denied any wrongdoing, in 2008, in Argentina, the company was accused
of sponsoring a drug trial that led to 14 infant deaths.
According to the Inspector General, in 2008, 80% of approved new drugs had clinical trials
abroad.
With new medical innovations coming out quicker than ever before, the FDA needs some updates
to its policies.
The recent bill to expedite drug approval may help the agency keep on track with the
rapid pace of development in the pharmaceutical industry.
Officials hold that FDA approval is a “gold standard” that is “recognized worldwide”.
Despite some growing pains, the FDA maintains extremely high standards for US citizens.
Many legal and illegal drugs are being produced in China - including one drug, called Flakka,
that caused several American deaths this year.
To find out more, check out our video about China’s role in the drug trade.
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