On the same day that the U.S. Food and Drug Administration proposed changes to how medical device approval is fast tracked via its 510(k) process to speed devices to the market, new legislation was introduced to improve <"https://www.yourlawyer.com/practice_areas/defective_drugs">drug safety, wrote The Hill.
Senator Michael Bennet introduced the legislation, which he said would significantly add to current FDA authority and would increase the onus drug companies face for accountability to the drugs they sell, explained The Hill.
Noting that we now live in a “globalized age,†said The Hill, Senator Bennet explained the issue with drugs and drug components that are manufactured overseas. “For too long, the FDA has lacked the proper authority to adequately safeguard our drug supply,” Bennet said, quoted The Hill. “Americans need to be able to trust that the drugs in their medicine cabinets are safe, no matter where they’re made,” he added.
Also yesterday, a poll was released by the Pew Prescription Project in which it was revealed that the majority of Americans—89 percent—support Congressional action to increase drug safety in the United States, with 58 percent indicating that they “strongly support,†these actions, wrote The Hill.
As expected, support is not coming from industry, and the drug lobby feels that additional consumer protections are unwarranted. Ken Johnson, a senior vice president of the Pharmaceutical Research and Manufacturers of America (PhRMA), a key lobbyist group for branded medications is among those who claim the proposal is not needed, wrote The Hill.
“Brand-name pharmaceutical companies make tremendous investments in quality control systems and take extensive measures to help protect patient safety and to help prevent adulterated ingredients from entering into America’s prescription drug supply,” Johnson said in a statement, quoted The Hill. “The U.S. regulatory system for prescription drugs is the toughest and safest in the world,” Johnson added.
Proposal supporters disagree, pointing out that in 2009 alone, the U.S. saw a massive 400 percent increase in drug recalls over the prior year; 1,742 drugs, said The Hill. Also, over 100 Americans died in 2007 and 2008 just from the Chinese-manufactured blood thinner heparin in a widely publicized debacle that pointed to unsafe, unsanitary drug manufacturing practices, a significant issue given that most of the active ingredients—proposal supporters claim 80 percent—in pharmaceuticals targeted to U.S. consumers, are made overseas where regulations are not as strict as in the U.S., noted The Hill.
The proposal would include an enhancement to FDA systems that would enable tracking of international manufacturers providing ingredients and drugs to the U.S., mandate firms document each contributor in the product‘s cycle, allow the agency subpoena authority when investigating firms and products, and allow—finally—the FDA to recall drugs when safety issues become evident, said The Hill. Today, the FDA does not have the power to recall medications.
