Sharon Phillips, Marketing Communication Specialist, MasterControl, Inc.
For Pharmaceutical and Medical Device Companies
Although essentially the same as its 2008 predecessor, the recently announced Drug and Device Accountability Act of 2009 is much more likely to become law in today's more favorable, "accountability-conscious" political climate.
If and when this happens, the bill will subject product applications that contain false or misleading information to stiff fines (up to $5,000,000), and these fines will be assessed both to companies and their senior officers, who, in addition, will face jail sentences of up to 20 years.
The bill will subject product applications that contain false or misleading information to fines up to $5,000,000, and these fines will be assessed both to companies and their senior officers, who, in addition, could face jail sentences of up to 20 years.
According to Senator Grassley (R-IA), who is cosponsoring the bill with Senator Edward Kennedy (D-MA), the proposed legislation is in response to the alarming increase in the number of drugs and ingredients for pharmaceuticals being manufactured in other countries. This, despite the fact, according to Grassley, that "studies show that the FDA conducts relatively few foreign inspections each year."
Grassley also cites serious allegations that have been raised by scientists within the FDA regarding the agency's handling of medical device reviews.
Specifically, as in the Drug and Device Accountability Act of 2008
, the Drug and Device Accountability Act of 2009 bill covers:
- Enhanced registration and inspection requirements for drugs and devices
- Safeguards for ensuring the identity and sourcing of drug ingredients
- Safeguards for ensuring standards for imported drugs
- Enhanced responses to unsafe drugs and medical devices, including stiff fines and possible imprisonment
- Certification of information submitted by senior officers and directors of companies
- Whistleblower protections
The types of submissions affected by the Drug and Device Accountability Act of 2009 are consistent with those in the 2008 Accountability Act and are listed below. The sections referenced apply to the Federal Food, Drug, and Cosmetic Act, unless otherwise indicated.Drug Submissions
Medical Device Submissions
- a new drug application under section 505(b)
- an abbreviated new drug application under section 505(j)
- a biologics license application under section 351 of the Public Health Service Act
- an application for an investigational new drug exemption under section 505(i)
- a new animal drug application under section 512(b)
- an abbreviated new animal drug application under section 512(b)
- an application under section 571
- a request under section 572
- all other submissions affected by this Act and, if applicable, by section 351 of the Public Health Service Act
- an application or report for pre-market approval under section 515
- an application for an investigational device exemption under section 520(g)
- a report under section 510(k)
- an application for a humanitarian device exemption under section 520(m)
- an amendment, supplement, or other information submitted to the Secretary of Health and Human Services with respect to any application or report, or a record or report related to an adverse event
- a report or postmarket surveillance study under section 519 or 522
The likelihood of the passage of the Drug and Device Accountability Act of 2009
makes it more imperative than ever for drug and medical device companies to adopt a proactive approach and take a serious look at all facets of their quality assurance programs. If they have not already done so, companies should seriously
- Adopting a centralized, Web-based document control system for enhancing senior management oversight of all a company's processes.
- Implementing integrated quality software solutions for managing -
- Product development and design
- Clinical trials or product testing
- Production processes
- Employee training
- Quality management software and training for helping companies evaluate and correct adverse events and other risk situations due to customer complaints, out-of-specification processes, deviations and nonconformances, etc.
- CAPA software for quickly resolving risk issues that elude preliminary investigations and entail more extensive investigation.
Sharon Phillips is a marketing communication specialist at MasterControl, Inc. For more information in regard to MasterControl please feel free to contact a MasterControl representative.
Full US Senate Press Release: http://finance.senate.gov/press/Gpress/2009/prg042309.pdf
Full text of the 2009 Drug and Device Accountability Bill can be retrieved from: http://finance.senate.gov/press/Gpress/2009/prg042309j.pdf