Posts tagged with "Food and Drug Administration"

A remedy for rip-offs: HHS announces plans to import lower-cost drugs from Canada

August 1, 2019

The U.S. Department of Health and Human Services (HHS) announced on July 31 that the agency, in concert with the U.S. Food and Drug Administration (FDA, is publishing a Safe Importation Action Plan for procuring certain drugs originally intended for foreign markets.

Among the medications that U.S. patients would be able to procure at lower prices would be insulin used to treat diabetes, as well as drugs used to treat rheumatoid arthritis, cardiovascular disorders, and cancer.

Specifically, according to a report by the Associated Press, the Trump administration said Wednesday it will create a pathway allowing Americans to legally and safely import lower-cost prescription drugs from Canada for the first time, reversing years of opposition from federal health authorities amid a public outcry over high prices for life-sustaining medication

“President Trump has been clear: For too long American patients have been paying exorbitantly high prices for prescription drugs that are made available to other countries at lower prices,” stated said Health and Human Services Secretary Alex Azar, adding, “When we released the President’s drug pricing blueprint for putting American patients first, we said we are open to all potential solutions to combat high drug prices that protect patient safety, are effective at delivering lower prices, and respect choice, innovation and access.”

Azar further noted, “This is the next important step in the Administration’s work to end foreign freeloading and put American patients first.”

The Action Plan outlines the government’s intention to pursue two pathways to allow safe drug importation from foreign markets:

  1. Through a notice of proposed rule-making (NPRM), HHS and FDA would propose to rely on the authority under current federal law (Federal Food, Drug, and Cosmetic Act, Section 804) that would, when the rule is finalized, authorize pilot (or demonstration) projects developed by states, wholesalers or pharmacists and submitted for HHS review, outlining how they would import certain drugs from Canada that are versions of FDA-approved drugs that are manufactured consistent with the FDA approval. The NPRM would include conditions to ensure the importation poses no additional risk to the public’s health and safety and that the demonstration projects would achieve significant cost savings to the American consumer.
  2. Through guidance, FDA would provide recommendations to manufacturers of FDA-approved drugs who seek to import into the U.S. versions of those drugs they sell in foreign countries. Under this pathway, manufacturers would use a new National Drug Code (NDC) for those products, potentially allowing them to offer a lower price than what their current distribution contracts require. To use this pathway, the manufacturer or entity authorized by the manufacturer would establish with the FDA that the foreign version is the same as the U.S. version and appropriately label the drug for sale in the United States. This pathway could be particularly helpful to patients who take significantly high-cost prescription drugs.

“We support the President and Secretary’s efforts to bring down drug prices for Americans. The FDA has a unique role to play in promoting competition that in turn can help reduce drug prices and improve access to medicine for Americans,” said Acting FDA Commissioner Ned Sharpless, M.D. “Driving down drug prices requires a comprehensive approach and we must continue to look at all innovative solutions to this challenge.”

Research contact: digital@hhs.gov

As spending on consumer drug advertising skyrockets, experts advise ‘healthy skepticism’

January 24, 2019

If you spend any time watching television, you are bound to see “real people” who appear to be healthy and happy bicycling down the road, hugging a grandchild, walking on the beach, or working in the garden. They mention the consonant-heavy name of a pharmaceutical drug you could use. “Ask your doctor, “an announcer suggests, after spouting the product’s benefits—and speed-talking her way through a scary list of side effects.

And it’s not just one ad; it’s several per prime-time show: A recently televised sporting event, for example, featured one ad for a drug to help you fall asleep, followed by another to keep you awake, according to an editorial in JAMA  that was written by Howard Bauchner, M.D., and Phil B. Fontanarosa, M.D., (who are, respectively, the editor and executive editor of the Journal of the American Medical Association).

Indeed, according to a Dartmouth College study, over a 20-year period, from 1997 through 2016, drug marketing increased dramatically—from $17.7 billion to $29.9 billion; while regulation did not.

“Because the goal of medical marketing is to shape our perceptions of the benefits and harms of drugs, treatments, and even of diseases, themselves, it can have a very significant impact on healthcare and can even hamper efforts to control unsustainable healthcare spending,” says Dartmouth Institute Professor for Health Policy and Clinical Practice Steven Woloshin, MD, who co-authored the paper with his wife and longtime research partner, the late Professor Lisa Schwartz, MD. (Dr. Schwartz passed away in November 2018).

In their review of spending, Schwartz and Woloshin found that the most rapid increase was in direct-to-consumer (DTC) advertising, which increased from $2.1 billion (11.9% of total spending) in 1997 to $9.6 billion (32% of total spending) in 2016. 

Over the same time period, the total amount consumers spent out-of-pocket on their prescription medication also skyrocketed to $328.6 billion from $116.5 billion (after industry rebates and discounts), the study found.

Why the explosion in drug ads over the past 20 years? The study notes that in 1997 the Food and Drug Administration began allowing drugs ads to mention side effects with voice-overs, instead of scrolling through a visual list on the screen, which takes more time. Shorter ads can allow for more ads, says Dr. Woloshin.

Another possible explanation is that at the same time that drug companies are spending more on drug ads directed at consumers, they’re also spending more marketing the new drugs to physicians, says Adriane Fugh-Berman, M.D., an associate professor in the department of Family Medicine at Georgetown University who has studied drug advertising. That can increase “irrational prescribing and overuse of medication,” Dr. Fugh-Berman recently told Consumer Reports.

Perhaps the most important reason for the increase: “The ads work,” Woloshin says. “They increase patient requests and prescriptions for advertised drugs, even when there are lower-cost alternatives.”

Indeed, Consumer Reports notes, numerous studies suggest that drug ads increase healthcare costs by promoting higher-cost medications when lower-cost, older ones might work as well.

In recent years, the consumer-oriented news outlet reports, many TV drug ads have focused on expensive drugs used to treat relatively uncommon, and hard to treat, conditions, such as rheumatoid arthritis, psoriasis, rare cancers, and seizures, according to figures from Kantar Media for the year ending in October 2018.

What’s an inundated consumer to do? The magazine warns, those sorts of pricey meds may not be covered by your insurance, especially if you get insurance through your employer. A 2017 survey of employers by the Pharmacy Benefits Management Institute found that when it came to high-cost medications, most of the insurers required a person to try other medications first, required a person to obtain approval from the insurer for expensive medications before filling a prescription, or limited the amount of the drug a person could obtain. Fully 75% of employer plans simply did not cover certain drugs, including high-cost drugs, according to the survey.

There are alternatives, Consumer Reports advises: For complicated medical conditions, which may necessitate higher-cost medications, work with your physician and insurance plan to find covered treatments. Also check NeedyMeds for the drug you’re being prescribed to see what Patient Assistance Programs, manufacturer coupons, or other discounts might be available.

Research contact: steven.woloshin@dartmouth.edu

FDA approves first generic version of EpiPen

August 20, 2018

When it comes to life-threatening allergic reactions, time is of the essence. Whether it’s a peanut allergy, a bee sting, a reaction to a medicine, or some other serious hypersensitivity, it is crucial for many Americans to have the correct drug on-hand and ready-to-use at a moment’s notice. Anaphylaxis occurs in approximately one in 50 Americans. People who have had an anaphylaxis episode always face the risk of another one. Because of this risk, they must carry an emergency dose of epinephrine at all times. Many must keep more than one dose at hand.

However, until now, the expense and frequent lack of availability of such pharmaceuticals has been a problem. Not anymore: The U.S. Food and Drug Administration announced on August 16 that the agency has approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds. When given intramuscularly or subcutaneously, it has a rapid onset and short duration of action. Epinephrine works by reducing swelling in the airway and increasing blood flow in the veins.

Teva Pharmaceuticals USA gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths. Teva spokesperson Doris Saltkill said the price of the drug and the exact launch date were not yet available, but the company’s statement suggested it would not be in time for many parents who are scrambling to find EpiPen in their pharmacies now. “We’re applying our full resources to this important launch in the coming months and [are] eager to begin supplying the market,” the statement said.

“Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval,” said FDA Commissioner Scott Gottlieb, M.D. “This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages.

“The path to developing generic drug-device combination products like this one is challenging,” Gottlieb commented.”We remain committed to doing our part to provide scientific and regulatory clarity for sponsors seeking to develop complex generics, as well as prioritize the approval of medicines with little or no generic competition as part of our overarching effort to remove barriers to generic development and market entry of critically important medicines. Many of these steps were outlined in our Drug Competition Action Plan, announced last year. We’re especially committed to the development of generic copies of complex products. These products can be hard to copy, and therefore sometimes don’t face timely generic competition once patents and exclusivities are no longer a block to approval. We’re advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we’re prioritizing review of many complex generic drug applications.”

The FDA has approved several epinephrine auto-injector products under new drug applications to treat anaphylaxis, including EpiPen, Adrenaclick and Auvi-Q. In addition, “authorized generic” versions of EpiPen and Adrenaclick are marketed without the brand names. An authorized generic is made under the brand name’s existing new drug application using the same formulation, process and manufacturing facilities that are used by the brand name manufacturer. The labeling or packaging is, however, changed to remove the brand name or other trade dress. In some cases, a company may choose to sell an authorized generic at a lower cost than the brand-name drug product.

The most common side effects associated with epinephrine injection are anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache and/or respiratory difficulties. Rare cases of serious skin and soft tissue infections have been reported following use of the drug. In patients with heart disease, use of epinephrine injection may cause chest pain (angina pectoris) or abnormal heart beats (ventricular arrhythmias). Following use of epinephrine injection, patients should seek immediate medical or hospital care. Epinephrine should not be injected into the vein, buttock, fingers, hands or feet. To minimize risk of injection-site injury, movement of the leg should be limited during injection.

Research contact: fdaoma@fda.hhs.gov

The best protection under the sun

June 26, 2018

It is finally summer—and Americans are leaving their homes in droves to enjoy the balmy temperatures and sunshine in their backyards, parks, pools, and beaches. Most of us feel that moderate exposure to sun improves our health, appearance, and mood. But we also know that too much of a good thing can be dangerous—causing everything from skin rashes to sunburns, to sun poisoning to cancer. So why is it that so few of us use sunscreen when we are out and about?

Indeed, according to the U.S. Centers for Disease Control, fewer than 15% of men and 30% of women report applying sunscreen to their faces and other exposed skin when they leave the house (or the office) for more than an hour. Women are more likely than men to apply sunscreen to their faces, in order to avoid the aging effects of too much sun—–perhaps accounting for their greater usage.

Sunscreen use is particularly low among men, non-Hispanic blacks, people with less sun-sensitive skin, those who do not get the recommended amount of weekly aerobic physical activity, and people with lower incomes (under $60,000), the CDC reports.

Another demographic that is likely to skimp on sunscreen is teenagers. Following a study by William Paterson University in Wayne, New Jersey, in 2011, lead researcher Corey Basch, an associate professor in the school’s Department of Public Health, commented, “Unfortunately we found a decrease in the overall percentage of teens who reported wearing sunscreen—[down] from 67.7% in 2001 to 56.1% in 2011.

And even when they do look for sunscreen, many Americans don’t know which type really is best for them. According to the Food and Drug Administration , that would be “broad spectrum” brands that protect against both ultraviolet A and B radiation with an SPF of 30 or higher. UVA rays are believed to be responsible for the aging and wrinkling of skin; UVB rays are the culprit that causes cancer.

That seems easy enough, but, the CDC again has some bad news for us: Nearly 40% of sunscreen users were unsure if their sunscreen provided broad-spectrum protection.

Top brands

For those who could use some help with their choices, Consumer Reports ranks commercially available sunscreens each year. According to the researchers at Consumer’s Union, the following products scored 81 or higher overall and were rated excellent or very good for UVA and UVB protection:

  • La Roche-Posay Anthelios 60 Melt-in Sunscreen Milk SPF 60 ($36, or $7.20 an ounce, score of 100);
  • Equate Sport Lotion SPF 50 ($5, or 63 cents an ounce, score of 99; and
  • BullFrog Land Sport Quik Gel SPF 50 ($8.50, or $1.70 cents an ounce, score of 95).

The magazine also rated the top spray and stick sunscreens—two of which rated highly:

  • Trader Joe’s Spray SPF 50+ ($6, or $1 an ounce, score of 100); and
  • Up & Up (Target) Kids Sunscreen Stick SPF 55 ($8, or $6.67 an ounce, score of 85).

Among natural sunscreens, California Kids #Supersensitive Lotion SPF 30+ scored highest. It received an overall score of 55 and costs $20 a package, or $6.90 an ounce.

The report recommends against using sprays on kids until researchers know more about the dangers of inhaling them. If you do use them, Consumer Reports suggest spraying the solution onto your hand, then rubbing it into your skin.

Application tips

Among the recommendations for applying such products are the following, according to the American Academy of Dermatology:

  • Apply sunscreen generously 15 minutes before going outdoors;
  • Use enough—at least one ounce for an adult (about the amount you can hold in your palm) to fully cover your body;.
  • Remember your neck, face, ears, tops of your feet, and legs;
  • Use a balm with an SPF of at least 15 for your lips; and
  • Reapply sunscreen at least every two hours, or immediately after swimming or sweating.

Finally, using sunscreen should not be your only defense against the sun. For the best protection, the experts  says, stay in the shade and wear protective clothing, a hat with a wide brim, and sunglasses, as well as sunscreen.

Research contact: 1-800-CDC-INFO