With the new User Fee Bill, safer overseas supply chain can be made possible.
Safe supply chain provides users with quality goods for consumption, protecting their health and safeguarding their welfare. With the new User Fee Bill put in place, generic makers will have to pay an inspection fee. This would be part of the Generic Drug User Fee Act (GDUFA).
This new legislative is strongly supported by many in the industry who believes that all drug production facilities, both foreign and domestic, should be inspected. The implementation of the bill also marks a step towards a more harmonized system internationally. According to experts of the industry, the lack of harmonization has always been a problem, increasing costs and inducing inefficiency. With this new bill, a more secure, efficient and safer supply chain can be expected.
Such a move will also shorten generic reviews by 3 folds, from 30 months to 10 months and this can be seen as an incredible move towards a more productive system.
The SOCMA (Society of Chemical Manufacturers and Affiliates) said: "The GDUFA levels the playing field for domestic pharmaceutical producers by requiring that all foreign and domestic drug production facilities be inspected, a key step in improving the supply chain."
No doubt there are indeed pros and cons to the employment of this new rule. Some argued that the federal deficit will be increased by $247m over the next decade because of this move. However, the FDASIA also pointed out that the new act can also reduce spending by $750m over the same period. With this, the decision can be said to be a "win-win".
This new bill also implies the reauthorization of the Prescription Drug User Fee Act (PDUFA) which require drug makers to pay fees totaling $4.1bn over the next five year.
Hopefully, with all these new bills in place, the pharmaceutical supply chain can be made safer for consumers all over the world.
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Article adopted from in-Pharma Technologist.com