The recent decisions taken up by the US Congress could put a halt on the current pace of drug and medical device reviews. According to latest news from the FDA, the agency must receive a certain amount of funding from Congress before it can spend any of the money pertaining to the drug and medical device industry.

With this decision if Congress doesn’t agree on a federal budget and gets it passed, it would be tough for the agency to examine and review the drug and medical device approval applications. However, the ultimate burden and risk would be put on the shoulders of consumers who invest a huge amount of money to avail these medical devices and drugs.

With this move the U.S. Food and Drug Administration (FDA) reviews of medical devices like trans-vaginal mesh, hip implants, knee implants could reduce the pace of medical review process to a much slower rate.

According to various experts from the drug and pharmaceutical industry, lawmakers are all set to keep the FDA in limbo while the agency is all set to cut $1.2 trillion from the government budget over the next decade.

It is important to underline here that for the fiscal year of 2013, the US Government has requested about $2.5 billion in taxpayer funds for the agency. Keeping this much money aside the agency is also supposed to get a huge sum collected from various medical device proceedings which includes $299 million for generic drugs and medicines, $98 million from medical device companies and an additional $2 billion as industry fees.

The move was taken on the light of the inaction of 3rd Medical Device User fee & Modernization Act that was approved by the US Congress in August and will be effective for next five-year period. The tenure for the act is all set to be in effect, beginning 1st October 2012. However, it depends on the status of the deal between medical industry group and the FDA. The 3 medical industry groups that are involved in the lobbying are the Medical Device Manufacturer Association, Medical Imaging and Technology Alliance and the Medical device Manufacturers Association.

Meanwhile, manufacturers have agreed upon to bear the increased fee in lieu of more efficient and prompt regulatory approval process. The pact clearly indicates that there is an urgent need to increase the level of productivity in upcoming years and hence the pact.

Meanwhile it is important to know that The FDA is entitled to receive a sum of money as a fee when drug companies and medical device organizations register their establishment and launch their devices on the market. All companies and organizations that submit a New Drug Application (NDA) or notify to the agency about their device had to submit a huge amount of money as a fee which FDA utilizes to approve and examine the process of approval.

According to various reports from the medical and pharmaceutical arena if the proposed budget is not approved the agency would run out of adequate funds and the agency would have to look for some alternative sources to maintain their personnel cost. In case of such a policy paralysis the agency would have to lay off the workforce needed to control the workload.