We strongly encourage ONC to include automatic identification and data capture (AIDC) such as bar codes in its 2015 Edition and not wait until the 2017 Edition. Using an AIDC system saves physicians time and is more accurate (it avoids human error such as transposing of numbers). Adding UDI information to EHRs would improve patient care in several ways.
These are the issues that cross cut over all the other ones, such as the importance of patients’ access to accurate information about medical products, improving communications between doctors and patients, decreasing discrimination and disparities in health care, and ensuring appropriate gender, racial, ethnic, and age diversity in clinical trials.
We are writing to thank you for your dedication to patients and consumers through your work to strengthen safeguards for all medical products sold in the United States. Your continued efforts through the years, including your recent letter to the FDA Commissioner, is needed now more than ever to help preserve the public health mission of the FDA.
We strongly support the FDA’s ban on importing drugs manufactured at Ranbaxy Laboratories, Ltd.’s facility in Mohali, India. The company’s facility is not complying with current good manufacturing practices (cGMP), which are the main regulatory safeguard to ensure drug manufacturing quality.
We generally support the VALID Act because it will give the FDA the clear regulatory authority it needs to prevent tragedies such as the contaminated steroid injections that have resulted in hundreds of cases of fungal meningitis and more than 30 deaths. However, Congress should absolutely clarify the legal status of section 503A, which should be revised to delete the unconstitutional advertising provision.
We welcome the opportunity to provide our views regarding pharmacy compounding. Stronger regulations are clearly needed to prevent tragedies such as the contaminated steroid injections that have already resulted in 356 cases of fungal meningitis and 28 deaths. Current laws and regulations regarding compounding pharmacies have resulted in giant loopholes that allow medical products that are neither safe nor effective to be sold throughout the country, putting patients’ lives at risk.
We agree with the Institute of Medicine and the Medicare Payment Advisory Commission (MedPAC) that “enhanced disclosure and transparency [is needed] to discourage the inappropriate use of financial incentives and lessen the risk of such incentives interfering with medical judgment and patient care.” While we strongly support the proposed rule overall, there are several major loopholes that need to be fixed.