Source Pravda.Ru

FDA asks for additional funds after wave of criticism

The Food and Drug Administration addressed the Congress Monday with a request to allocate $275 million for import protection. The FDA asked for the additional amount after the agency was criticized for its attempts to do too much with insufficient resources.

With the help of this amount the FDA will hire 490 people and establish a presence overseas. In addition, the agency will modernize its information technology infrastructure and hold more inspections in other countries.

House lawmakers criticized the FDA in April for its insufficient inspections of foreign pharmaceutical companies. The criticism followed a string of problems with contaminated doses of blood thinner, which most likely arrived from a Chinese plant that the FDA never inspected.

The additional amount will let the FDA conduct at least 1,000 more inspections of food and medical products and their facilities in foreign countries. About 1,000 more inspections will also be conducted inside the USA.

In March 2008, major recalls of heparin were announced by the FDA due to contamination of the raw heparin stock imported from China. The FDA admitted that it had violated its own policies by failing to inspect the American pharmaceutical firm Scientific Protein’s plant in China before approving the drug for sale. The U.S. Food and Drug Administration was quoted as stating that at least 19 deaths were believed linked to a raw Heparin ingredient imported from the People's Republic of China, and that they had also received 785 reports of serious injuries associated with the drug’s use. According to the New York Times: 'Problems with heparin reported to the agency include difficulty breathing, nausea, vomiting, excessive sweating and rapidly falling blood pressure that in some cases led to life-threatening shock'.

The contaminant has been identified as an "over-sulphated" derivative of chondroitin sulfate, a popular shellfish derived supplement often used for arthritis. Since this "over-sulphated" variant is not naturally occurring and mimics the properties of heparin, the contamination could be an intentional counterfeit as opposed to an accidental lapse in manufacturing.

More than 5.8 million people voted for Nicholas Maduro at the presidential election in Venezuela. This is more than a quarter of registered voters. Why did those people vote for the man, who, as Western media write, took Venezuela to the brink of collapse?

Venezuela may expect another Panama scenario from 1989
Comments
Ukraine's exit from Commonwealth of Independent States will affect common Ukrainians most
USA sanctions Russian oligarchs and heads of state-run companies
USA sanctions Russian oligarchs and heads of state-run companies
USA sanctions Russian oligarchs and heads of state-run companies
Ukraine's exit from Commonwealth of Independent States will affect common Ukrainians most
Russian air defences ready to shoot down NATO drones and reconnaissance aircraft over Crimea
Ukraine's exit from Commonwealth of Independent States will affect common Ukrainians most
Russian air defences ready to shoot down NATO drones and reconnaissance aircraft over Crimea
Russian air defences ready to shoot down NATO drones and reconnaissance aircraft over Crimea
Russian air defences ready to shoot down NATO drones and reconnaissance aircraft over Crimea
British football fans spineless to unleash World War Three in Russia during World Cup
Russian air defences ready to shoot down NATO drones and reconnaissance aircraft over Crimea
British football fans spineless to unleash World War Three in Russia during World Cup
Beautiful and terrifying: Russia shows video of Bulava ICBM underwater salvo launch
Kremlin on failed nuclear missile tests: 'Listen to President Putin and believe him!'
Kremlin wants foreign invaders out of Syria
Kremlin on failed nuclear missile tests: 'Listen to President Putin and believe him!'
What may happen to foreign tourists traveling for 2018 World Cup in Russia
Kremlin on failed nuclear missile tests: 'Listen to President Putin and believe him!'
Russian special services detain Hizb ut-Tahrir members in Crimea
Russian special services detain Hizb ut-Tahrir members in Crimea