Across the country it was a hot, hot week. Triple digits nearly all over the West and wildfires breaking out in several states. There were wildfires here inside the Beltway too, all between Congress and the Administration. And for those of us concerned about the pharmaceutical market, there was a great deal going on:
- Chinese Former FDA Head Executed – And people think Washington is a tough town. In China, the former chief of the country’s FDA was executed for graft. This is perhaps one of many ways that country will be trying to demonstrate responsibility regarding its pharmaceutical industry. One official was quoted in the Washington Post story on the matter as saying "[w]e should seriously reflect and learn lessons from these cases. We should step up our efforts to ensure food and drug safety, which is what we are doing now and what we will do in the future…"
- House Passes Bill for FDA Reform – On Wednesday the House passed its version of the already passed Senate Bill for PDUFA funding that would allow an expansion of FDA authority, particularly over post-marketing studies, and raise the stake of industry funding for FDA enforcement activities. The vote was 403-16. Interestingly, false or misleading ads could lead to large fines. This is in spite of the fact that since President Bush took office, the Warning Letters issued by DDMAC have plummeted to a mere trickle.
- FDA Again Warns Consumers Against Internet Purchases – The FDA issued an alert warning consumers of Internet purchases with a release titled "FDA Finds Consumers Continue to Buy Potentially Risky Drugs Over the Internet Practice Puts Consumers at Risk and May Be More Expensive than Domestic Purchasing". If the FDA continues to wonder why consumers choose not to heed their warnings, they might want to consider the lack of credibility that the agency has and that, in fact, right now the entire Administration suffers. In addition, without addressing the risk of American counterfeiting in conjunction with foreign counterfeiting, these warnings present only part of the picture. For those interested, however, the link provided here does show a compilation of FDA’s findings.
That’s it for this week. Have a good weekend everyone!