FDA’s policies and practices help to drive drug prices higher. No doubt, you have read stories implicating the FDA in helping to drive prices higher. Specifically, the government uses 2 policies and practices that drives drug prices higher:
- The US grant monopoly protection to drug manufacturers: With monopoly protection (no competition) pharmaceutical companies are free to charge whatever price they wish. One example; Sofosbuvir a Hep C drug that boosts a cure rate of 90% cost patients $84k in the US. Compared to drug treatment in India where competition exists, patients pay $336 for the same cure rate.
- Imposing coverage requirements on government-funded drug benefits:
The requirement stated that most government drug payment plans cover nearly all products, which eliminates the patients or anyone else’s ability to negotiate prices.
5 realistic short-term strategies could address high drug prices:
- Enforcing more stringent requirements for exclusivity rights privilege
- Enhancing competition with generic drug
- Providing greater price negotiation by governmental payers
- Better cost comparisons and effectiveness of therapeutic alternatives
- Educating patients, prescribers, payers, and policy makers about these choices.
The US spends more on prescription drugs than every other country. In 2013, Americans were spending $858 per person compared to $400 for other industrial countries. Drug manufacturers are awarded exclusive market rights by the Food and Drug Administration (FDA). To be fair, it is very costly for drug manufacturers to bring their products to market. For many, the cost to market can exceed $1 billion. These costs include research and efficacy testing to ensure consumer safety regulated by the FDA. This has led many populous politicians to propose reducing regulations. Cutting regulations always sound like a great idea, until people start dropping dead because lower regulations mean lower standards.
After the patent expires (exclusive agreement), generic drugs enter the market reducing drug costs. The negotiated price is the primary driver behind high drug prices. The 2nd contributor to high drug prices is physicians preference of prescribing name brand versus a generic alternative when available. Lastly, drug manufacturers site the high cost of drug development as the reason for high drug prices. Independent research has not shown a correlation between the cost of development and drug pricing. Pharmaceutical companies primarily set the price based on market conditions.
Continue reading “Paying for Drug Performance”
FDA’s Accelerated Approval
There is an update regarding the FDA; it’s called accelerated approval. According to the Journal of the American Medical Association, accelerated approval occurs regardless of a lack of clear evidence of safety or effectiveness for both drugs and medical devices. The Accelerated Approval allows potentially promising medicines and medical devices available to the public before the usual amount of data has been collected confirm their effectiveness and safety.
Drugs granted accelerated approval bypass the rigors of evaluation using design theory methods to examine their clinical outcomes. These drugs are accepted for consumer consumption by the FDA, not due to their proven safety records rather their potential benefits. The FDA provides a gold standard randomized controlled trial for a drug’s safety and effectiveness. Many of the drugs granted accelerated approval were based on much less rigorous trials.
Medical Devices and Drug Safety
When the FDA approves medicines via Accelerated Approval, the agency should specify the limitations of the medical findings at the point of their fast track approval. In the case of medical devices, very few studies were randomized or blinded which means that it is not known if the devices are better than another treatment or no treatment at all. All of this is concerning because during the process information could become tainted or biased by the researchers.
Because of the FDA’s reputation, the public assumes the devices are safe and effective for what they are being used. Unfortunately, often this assumption is false. The public need to be protected and provided with full information regarding the safety of the drugs or their effectiveness. Doctors should be under a moral agreement to present these types of treatments without bias, so the public is fully informed.
Recently published reports show that patient who chose alternative therapies to treat a common curable cancer increased their risk of death, according to the Journal of the National Cancer Institute. By the time the alternative therapies are discovered to be ineffective the patient’s survival rate is in jeopardy.