HARRISBURG, Pa. - Should the federal Food and Drug Administration allow drug makers to modify their label information about side effects without government approval?

Allison Zieve, an attorney with the watchdog group Public Citizen, said most people are not aware that when they take generic drugs, they may unwittingly have surrendered some of their legal rights 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," Zieve said, "unlike a brand-name company, which you could sue."

Zieve said the original FDA rules covering generic versus brand-name drugs were written years ago, when generics weren't prescribed nearly as often as they are now.

"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 said. "So, the FDA rule is really a very important and overdue recognition that generic manufacturers need to be able to take responsibility for labeling."

Generic drugs often are much less expensive than name-brand drugs, which accounts for their popularity. Zieve noted that people should not decide that generic drugs are less safe than brand-name drugs, but added that 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 said. "The number of patients that have suffered because of the lack of adequate warnings is much bigger."

In Pennsylvania, pharmacists cannot substitute a generic drug for a brand-name drug when a physician prescribes a brand name and if small differences in dose or blood concentration could lead to adverse drug reactions. The substitution ban also applies if the doctor specifies "brand necessary" on the prescription.

The FDA is accepting public comments about the proposed change at FDA.gov.


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Virginia doctors are reminding people how important it is to stay heart healthy in extreme heat.

Temperatures across the U.S. have skyrocketed, and climatologists estimate 2024 will surpass 2023 as the hottest year on record. Virginia's average temperature has gone up almost 3 degrees in the last 20 years.

Dr. Deepak Talreja, clinical chief of cardiology at Sentara Health in Norfolk, said rising temperatures can be hard on your heart.

"The heart muscle is really susceptible to problems from heat, especially when a person gets dehydrated, or when they're not drinking enough fluid and they get their electrolytes off," Talreja explained. "That can cause rhythm problems, changes in blood pressure, and an increase in the risk of passing out."

Enough stress on the body ultimately leads to heart attack and stroke. Drinking water often is key to maintaining good heart health in the heat. While doctors said people should drink eight glasses of water daily, Talreja thinks people should drink 1.5 times that during extreme heat to stay hydrated.

Other drinks high in electrolytes are helpful for hydration but Talreja noted you should check the sugar content. High blood sugar with or without heat is harmful to the heart. He added there are misconceptions about caffeinated drinks in intense heat.

"Drinks with caffeine in them actually act as diuretics, they make you pee more and so, you have to be careful about heavily caffeinated beverages," Talreja advised. "Also, you have to be careful because you want to avoid beverages with a lot of sugar; sodas that cause excess weight, excess blood sugar."

Talreja noted another problem is not planning ahead and being in more heat than you may realize. He recommended anytime you go out, you should grab some water and know where to find a cool, shady spot.


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A critical shortage of direct care workers in Maine is leaving residents without needed health services, according to a new report.

It showed more than 23,000 hours of approved home care for older adults go undelivered each week, while waitlists for behavioral health care have grown into the thousands.

Arthur Phillips, analyst at the Maine Center for Economic Policy, said low pay and poor benefits make it tough to retain enough workers to meet demand.

"Even if you feel really dedicated to the work that you do and the people who you serve, if it's having negative impacts on your own life, then you're faced with a tough choice," Phillips pointed out. "I think a lot of people are leaving."

It is estimated the state needs to hire more than 2,300 direct-care workers just to meet existing needs. Phillips argued the state should raise its median wage for workers to at least 140% of the minimum wage to remain competitive or just under $20 an hour.

Maine already has the oldest population in the U.S. and the share of people age 65 or older is projected to grow to nearly 30% by 2050. AARP Maine estimates more than 160,000 unpaid caregivers, including family and friends, are currently filling the state's health care gap for the age group.

Phillips noted it can lead to greater stress on everyone and a loss of economic activity for the state.

"While we think that this will require significant resources and that this group of workers should be prioritized, I think it's also true that the costs of inaction are far greater," Phillips emphasized.

Phillips added the legislature raised the reimbursement rate for direct care workers in 2021, allocating some $120 million for recruitment and longevity bonuses, and needs to take action again. He recommended the state improve its data systems to get a clearer picture of Maine's health care needs, including both direct care workers and those they serve in the process of policy changes to ensure all needs are met.

West Virginia healthcare advocates are applauding a recent proposed rule by the Consumer Financial Protection Bureau to remove medical bills from credit reports.

As of last summer, about 5% of Americans had unpaid medical bills on their credit reports.

Healthcare Organizer with West Virginia Citizen Action Group Mindy Salango said more West Virginians are being forced to find ways to pay out of pocket, relying on credit cards and crowdfunding websites.

She added patients often receive unexpected medical bills and struggle to understand costs, making it difficult to compare medical debt to other loans.

"When you're going for an emergency surgery, they don't give you an outline of all the charges that you're going to be hit with," said Salango. "They do the surgery, and then you get the bill. If you go in to buy a car, they give you paperwork; you know exactly what you're signing on the dotted line for."

The proposed rule would close a regulatory loophole that has kept vast amounts of medical debt information in the credit reporting system, and would help prevent debt collectors from coercing payments for inaccurate or false medical bills, according to the Bureau.

Medical debt can lead to missed rent or mortgage payments, denied rental applications, and eviction. One study found 27% of Americans with medical debt have experienced housing-related problems.

Salango said erasing medical debt from credit reports will help more West Virginians stay in their homes.

"If you take these this off of a credit report," said Salango, "it's going to allow people to move into more stable situations."

She added there's been a significant spike in health insurance companies denying coverage, leaving consumers saddled with hefty bills.

"We're really fighting both federally and at a state level to stop these insurance companies from using predatory denials," said Salango. "Many of them are currently using AI to do initial denials."

West Virginia Citizen Action Group is hosting a town hall on June 25 in Huntington to help empower residents to dispute denials and understand how changes to Medicaid may affect their coverage.

More information about the event is online at wvcag.org.