Importation is a common practice in the business world since time immemorial. People exchanged goods and services from one region to another. Both sides benefited from this form of trade activity that has been taking place globally with the improved technology that has made the world a global village. When it comes to drugs and food, however, different nationalities have different rules and regulations that control the way food and drugs are manufactured and supplied to the people. In the USA, Food and Drug Administration (FDA) is the body that regulates the supply of medicine to the people. It is the organization’s duty to ensure that the citizens are provided with safe and high quality drugs that meet the desired effect when administered.
Basing on the past experiences, the former FDA commissioners are significantly warning against a move by President Donald Trump and Bernie Sanders to allow drugs to be imported to the US from Canadian manufacturers. Although the move is supposed to provide cheaper medicine to the citizens, according to the former commissioners who served during Obama and George Bush’s time, it will also pose a very high safety risk to the consumers. In the past, people have bought counterfeit drugs that led to various loss of lives. Internet pharmaceutical stores sell medications that are not necessarily manufactured in Canada or Europe even if they state so on their websites. Most of the drugs come from Mexican industries and risks the health of the American citizen.
Although regulating the quality of drugs manufactured in Canada to be imported to the US is possible, it is also tough to ensure that all the requirements are met. The closed system of drugs in the US may be expensive, but it safeguards the health of all citizens. Bringing drugs from Canada may end up being as expensive as the US drugs while risking the health of people because this will open other channels of backdoor drug markets sprouting from all over the country.
The commissioners, Robert Califf, Margaret Hamburg, Andrew von Eschenbach and Mark McClellan, have expressed their concerns saying …
A Federal Drug Administration subcommittee has approved the use of a drug to help relieve the problem of hypoactive sexual disorder in women. The drug called ADDYI was developed to restore sexual desire in women who have not yet reached menopause. Known within the medical community as HSDD, it is the most commonly reported form of sexual dysfunction in women and has been for the last 40 years. According to the drug’s manufacturer Sprout Pharmaceuticals, HSDD affects roughly one in three women, with one in ten reporting that their desire for sexual intimacy is very distressing. Once final approval is granted by the FDA, ADDYI will be the only drug on the market to address this disorder.
ADDYI is a non-hormonal drug that was tested in over 11,000 women making it one of the most studied and well-researched drugs coming to market. It acts on the patient by elevating the neurotransmitters dopamine and norepinephrine while reducing the levels of serotonin in the pre-frontal cortex of the brain. Dopamine and norepinephrine both act to enhance sexual desire and pleasure while serotonin acts to depress it. Studies showed that side effects of the drug were generally minor consisting mostly of nausea, dizziness and sleepiness.
The studies were conducted in double-blind tests over a 24-week period. In a double-blind study, neither the patient nor the administering physician knows whether the patient is receiving the actual drug or a placebo. Test subjects were screened and were selected to be in long term relationships for 10 years, and had HSDD for half of that time on average (4-5 years). Self-reporting from the patients showed that some experienced increased sexual desire in as early as four weeks, and by six months up to 60% reported improvement.
While the full FDA has not acted on the drug’s application, the recommendation by the sub-committee is a positive sign for ultimate approval. If it is approved it will be the first drug on the market that achieves the goals of enhancing women’s sexual response, the frequency for the desire of sex, and reducing the distress for the loss …