DENVER – According to Allison Zieve, an attorney with the watchdog group Public Citizen, most people are not aware that when you take generic drugs, you may have unwittingly surrendered some of your legal rights.

That's because of a 2011 Supreme Court ruling.

"If the labeling on a generic drug has failed to advise you of a safety risk, the Supreme Court has held you cannot sue the manufacturer for failing to warn you,” she explains, “unlike a brand name company, which you could sue."

Zieve says the original rules of the U.S. Federal Drug Administration covering generic versus brand name drugs were written years ago.

But now, the FDA is proposing a change that would allow the makers of generic drugs in many circumstances to modify their labels to add newly discovered risks or side effects, without going through a government approval process.

"Now, rather than them having a very small part of the market, generics have a huge part of the market – 84 percent of prescriptions filled,” she says. “So the FDA rule is really a very important and overdue recognition that generic manufacturers need to be able to take responsibility for labeling."

The FDA is accepting comments through today about this proposed change, and Zieve says you can go online at FDA.gov to voice your opinion.

She also points out that most consumers don't really choose whether they get generic drugs or not.

A doctor, pharmacist or insurance company often makes that decision.

She says if you have concerns about the safety or side effects of a drug you've been prescribed, you should discuss it with your doctor or pharmacist.

Often, generic drugs are much less expensive than name-brand drugs, which accounts for their popularity.

Zieve says people should not feel that generic drugs are less safe than brand-name drugs, but it's wise to get the latest information about risks and side effects.

"The number of drugs that this has affected over the years is probably not huge,” she says. “The number of patients that have suffered because of the lack of adequate warnings is much bigger."





get more stories like this via email

Health disparities in Texas are not only making some people sick, but affecting the state's economy.

A new study shows Texas is losing $7 billion a year because it does not adequately address quality-of-life issues and the health care needs of its lower-income residents.

The research was sponsored by the Episcopal Health Foundation, Methodist Healthcare Ministries of South Texas, and St. David's Foundation.

Brian Sasser, chief communications officer for the Episcopal Health Foundation, said health care includes more than doctors' visits and medication.

"Everything from increasing access to affordable health insurance to investing in under-resourced neighborhoods to give them more options, whether that's exercise options or food options," Sasser outlined. "Look at policy changes that expand health insurance coverage for new moms."

The report breaks down the economic costs of preventable health differences for every Texas county. It found Bexar, Dallas, Harris, Tarrant and Travis counties are losing the most money annually because of health disparities.

The amount of the economic impact depends on the racial and ethnic makeup of the county and the size of its working-age population. Sasser added the report shows Black and Hispanic children are more likely to grow up in neighborhoods with high poverty levels, and higher rates of diabetes and obesity.

"What can we do to work to make sure that the rate of diabetes isn't dramatically different between white households and Black households?" Sasser asked. "That we can make sure the food insecurity isn't dramatically different between someone who makes over $100,000 and someone who makes less than $30,000?"

The Texas Legislature has passed laws to address some of the disparities, including House Bill 12. It extends Medicaid health coverage for 12 months for new mothers, and pays for maternal health services for community health workers and doulas.

There is light at the end of the tunnel for Tennesseans struggling with opioid addiction, as a bill has been passed to increase access to treatment for opioid use disorder at Community Health Centers.

More than 3,800 lives were lost to overdose in the state in 2021, according to the Tennessee Department of Health.

Emily Waitt, policy and advocacy manager for the Tennessee Primary Care Association, said the original bill limited the number of patients nurse practitioners and physician assistants could treat with buprenorphine. The update removes the limitations, allowing more Tennesseans to access medication assisted treatment in their communities.

"It allows NPs and PAs to prescribe to 100 patients at a time, versus 50," Waitt explained. "Basically doubling the number of patients that they can prescribe to."

Community Health Centers serve more than 423,000 patients across Tennessee, regardless of their insurance status or ability to pay. About 7.7% of Tennesseans do not have health insurance.

Libby Thurman, CEO of the Tennessee Primary Care Association, said bringing the treatment to rural health centers expands access to a crucial service for patients who otherwise could not afford it. She noted it is important because people in remote areas often face challenges finding specialists and treatment facilities.

"We really wanted to work on this issue, because we know our Community Health Centers are where patients go for care," Thurman emphasized. "We really believe in an integrated model. So we want to treat the whole person, including if they are struggling with an addiction issue or a substance abuse disorder issue."

Health Centers offer behavioral health care, including counseling, along with treatment. The clinics also focus on creating a supportive network to help patients with family resources, job assistance and community connections.

While Black Maternal Health Week is wrapping up, health disparities for pregnant Black women continues to be an issue.

From April 11-17 this year, the high death rate of Black mothers is in the spotlight. Black women are three times more likely to die from pregnancy-related causes than their white counterparts.

Dr. Patricia Egwuatu, a family practice physician at Kaiser Permanente in Seattle, said racism is at the root of the disparities, which create barriers to health care access. She pointed out lack of access can lead to problems during pregnancy that are preventable or treatable.

"They may exist prior to pregnancy and then it gets worse during pregnancy if it's not managed as part of that maternity care," Egwuatu emphasized. "There are more pregnant women that have chronic conditions such as hypertension, diabetes and heart disease that are amplified during pregnancy."

The White House released a proclamation recognizing Black Maternal Health Week. The Biden administration began recognizing the week in 2021.

Egwuatu noted there are some warning signs any pregnant woman should be aware of and check in with their physician if they develop.

"You might get some changes in your vision that is not your normal. So, like, fuzziness, you can't see as well, or an excruciating headache," Egwuatu outlined. "You could also develop new swelling in your lower extremities that's making it difficult to get around or even new shortness of breath."

Egwuatu stressed physicians also need to recognize the role of racism in medicine. She argued continuous medical education is important for learning how to confront biases, and it is important for doctors to understand how they can provide people with resources.

"Asking the questions about personal barriers," Egwuatu suggested. "Does a patient have issues with getting to work, child care, transportation? What's their education, what's their cultural background and language? And do they even have a cell phone so we can connect with them?"