Author: Setareh Mobaraki

FDA has now approved Hepatitis C (HCV) drugs for children ages 12 to 17, which speed recovery and treatment. HCV is a blood-borne infection, causing inflammation to the liver, which can lead to liver failure, cancer and ultimately death. While HCV is attributed to sharing needles, which results in transferring contaminated blood, 20% of children get it from drug use. With HCV, one can become infected and not notice the symptoms until much later.

Research indicates that around 23,000 to 46,000 children are infected with HCV.  A baby only has a 6% chance of getting it while in their mother’s womb, and most children can clear the virus on their own by the age of 7. Those who do not clear the virus by the time they are two years old are chronically infected with HCV. Two drugs that the FDA has approved, and which have been highly effective thus far, are Harvoni and Solvadi. Harvoi and Solvadi are direct anti-acting antiviral drugs that prevent the virus, HCV, from multiplying, basically curing HCV. In clinical trials used on affected children, the two drugs have managed to eliminate all traces of the virus in the time frame of twelve weeks. Initially, the drugs were not even meant for children, causing doctors to be very hesitant in prescribing them before FDA approval.

As great as this may seem, the price for the drugs are costly. When the drugs first came out, the price was up to 100,000 dollars in the course of treatment. Medicaid restricted access to the drugs, and approved access to only those who had liver damage before treatment. Luckily, federal law states that Medicaid programs must cover “early and periodic screening, diagnostic, and treatment services” for children under 21.

HCV drugs treat a large population and there should be better access to expensive treatments. Because President Trump advocates for lowering drug prices, patients affected with HCV get the chance to access the otherwise expensive treatment. In 2015 alone, federal health programs spent more money on drugs for HCV than for any other drug. The Center for Medicaid and Medicare reported that Medicare Part D spent at least 7 billion dollars on the drug Harvoni, and Medicaid spending 2.2 billion.

The American Liver Foundation states that children with HCV should be receiving hepatitis A and B vaccinations, along with an annual influenza vaccine. Because children with HCV don’t usually exhibit obvious symptoms, their pediatricians should continue to monitor their growth and nutrition, and should have periodic screening of liver function through blood tests. Approving the drugs that cure HCV will significantly help children who might otherwise end up suffering from it; however, it’s important to keep in mind that the cost for the drugs are still expensive, and it cannot be given to children under the age of 12.

 

As biotechnology continues to advance, policies must catch up in order to properly regulate the safety and efficiency of technology. One of the popular and controversial advances in the scientific community is genome editing, which occurs when DNA is inserted, deleted or replaced in the genome of a living organism. While genome editing has mainly been used to modify foods, it has also been used on animals, and lately, on human embryos.

The new technology that is advancing gene editing is called clustered regularly interspaced short palindromic repeats (CRISPR). CRISPR allows scientists to alter DNA much more quickly than before, drastically impacting the health industry, since a parent can choose to decrease the risk of high cholesterol, or minimize the risk of getting cancer. According to Randall Lutter, a professor at University of Virginia, CRISPR is different from previous technologies because it can be used to affect heritable traits and thus create organisms with a variety of desired traits. The changes made in human cells could actually be passed down to future generations and would allow individuals to basically choose the traits they want for their children.

Despite some of the advantages of CRISPR, there are some concerns with how it can be used to engineer human embryos. This caused a dispute in the scientific community when the embryos used did not result in a live birth. Some scientists want to continue experimenting with the benefits and risks of genome editing, but others are fearful of the disruption it could cause in the ecosystem.

The 2017 updated version of the Coordinated Framework for the Regulation of Biotechnology describes the current statutory authority and regulatory programs, such as EPA, USDA, and FDA, as well as the safety and efficiency of biotechnology products. Under National Strategy for Modernizing the Regulatory System of Biotechnology Products, also known as The Strategy, the FDA will continue to update and clarify its policies in regards to gene editing, as well as finding new ways to improve coordination with federal research agencies.

Unlike previous technology, CRISPR doesn’t involve transgenics (which is when genes are inserted from foreign species into an animal or plant). Thus, the U.S. Department of Agriculture allowed it to be sold in the market place. However, this doesn’t mean the new device gets approval from the FDA. FDA’s process for approval of new products is somewhat slow. If the FDA does not approve this life changing technology, scientists will be forced in continuing to use older technologies that are not as efficient.

Even though genome editing can save lives, many are still skeptical on whether it should be used on human embryos. More research must be done in order to minimize the risks.  While CRISPR has made modifying DNA much less costly, it continues to raise regulatory and ethical concerns.

 

 

Many people already know that tobacco products such as cigarettes are injurious to their health, which is why they falsely believe that electronic cigarettes and cigars are a healthier substitute. In an effort to curtail this misconception, FDA has issued a new regulation on tobacco.

The FDA has been regulating tobacco since 2009. As of August 8, 2016, they have finally extended the rule to electronic cigarettes, cigars, hookah and other products that fit within the rule. The FDA’s authority has expanded, but it is for the protection of the public health. Part of the new regulation requires that tobacco manufacturers list all of the ingredients on their products by 2017. The new rule requires health warnings on “roll your own tobacco”, newly regulated tobacco products and cigarette tobacco. Free samples are also no longer permitted. The FDA will now be able to review all new tobacco products not yet in the market, which will ultimately help the FDA deal with misleading statements; thus, consumers will be correctly informed of what they are buying. Manufacturers will have to list their ingredients 90 days before the product is in the market. The rule has also prohibited sellers from selling to youths under eighteen, and consumers must now show photo identification.

A growing amount of teenagers have been using electronic cigarettes, otherwise known as e-cigarettes, because they believe that it is healthier than cigarettes. The data from the National Youth Tobacco survey indicated that 73 percent of teens believe e-cigarettes are less harmful than cigarettes. This perception is dangerous for youth because the e-cigarette actually delivers the same, if not more, nicotine than a conventional cigarette. Researchers have stated that this perception is related to their use of such products. But unfortunately, as noted by lead researcher Dr. Stephen Amrock, “children who use e-cigarettes than those who do not go on to use traditional cigarettes.” Hopefully, the new rule will increase youths’ awareness and decrease their misconceptions on alternative tobacco products.

As the new rule seeks to improve public health, it also causes a stir amongst businesses in the industry. Some business owners complain that they do not have the financial resources to comply with the regulations. The most concerning part is the “impossible pre market tobacco approval (PTMA) requirement” for products not on the market at that time. Businesses want a new date for new products, because under the current law, they argue, most products will be forced off the market. Business owners are currently reaching out to Congress in the hopes of changing the date for PTMA.

The new rule impacted businesses in the tobacco industry but it is necessary to combat the misconception on “safer” tobacco alternatives. As a result, the rule will help consumers and the vulnerable youth become more aware of their health, and the threat tobacco poses to it.