The FDA: Part 2

Rampant bribery partly explains the FDA’s illogical drug approval process. There are countless instances of where FDA officials have received bribes from lobbyists and pharmaceutical companies. The late 1980s is known to have multiple cases of drug manufacturers submitting fraudulent records, where FDA employees received gratuities in exchange for preferential treatment. In 1989, a series of generic drug scandals posted the mark for the FDA’s cozy relationship with the pharmaceutical industry. Ironically, it wasn’t the government that exposed the scandal, but the pharmaceutical company Mylan, who suspected corruption in the rapid approval of only certain manufacturers.

Despite so much corruption in the drug approval process, the FDA refuses to act. Republican U.S. representative Joe Barton of Texas, member of the House Energy and Commerce Committee, released a report describing the FDA’s debarment (or lack thereof) process:

More than 15 years ago, Congress passed a law to let the FDA kick out companies and individuals from the drug industry convicted of crimes related to the FDA approval process…This staff report shows in great detail the record of weaknesses in FDA’s ability and authority to carry out its duties and to protect its own integrity. When it comes to excluding the worst of the worst—convicted felons—FDA’s debarment process seems to be non-existent. It is inexcusable that the FDA can’t quickly debar convicted felons.

The FDA’s debarment list shows they have only used their debarment authority 9 times in over 15 years, during which from 2003-2005 alone, staff investigators found 40 convicted criminals. Even isolated cases where debarments did occur, the FDA delayed proceedings, sometimes for years at a time. Skewed, inconsistent rules allow the FDA to only debar generic manufacturers, while ignoring all corporations associated with brand-name drugs. Furthermore, the FDA cannot debar employees of medical device companies who are convicted of crimes that involve the FDA regulatory process. This is unbelievable. How are we supposed to reduce corruption in the drug industry when the FDA, our “provider” and “protector”, overlooks—and participates in—bribery and political favoritism?

This is not all to say a regulatory organization over the drug industry has no benefit, but the FDA has certainly harmed more than it has helped. It may be true that if the FDA prevented a deadly drug from entering the market, lives would be saved; however, statistics show that more terminal patients have died because they were denied access to unapproved medications. It may sound cruel to say drug companies should be able to release drugs to the market without a screening process, but telling a terminally patient he cannot take a drug that might save his life or improve his quality of life is even worse.

Hypothetically, Pfizer releases a drug to the market that on release kills twenty patients. Obviously this is horrible, but however “evil” you think pharmaceutical companies are, they will not continue to sell a drug that is killing its customers. The drug would be recalled immediately. And you don’t have to look at it in a moral context: in continuing to sell a fatal drug, Pfizer would risk a horrible public image and millions of dollars in litigation.

Now, twenty dead patients in itself might justify an extensive drug approval process. But if Pfizer’s drug caused zero fatalities, and within the next decade saves tens of thousands of lives, is the FDA still the benevolent guardian we perceive it to be? This may sound extreme, and maybe implausible, but there is no denying, FDA regulation hinders medicinal development. And with the drugs previously discussed, delaying or refusing lifesaving drugs, from an organization that is known for corruption, is an act of genocide.

The bureaucracy that surrounds the FDA is malignant, a cancer to American health care, as it disrupts medical progress and euthanizes the terminally ill. The FDA denies and prolongs the approval of lifesaving medications; it keeps new medical equipment, such as bone screws, joint replacements, and healing products, off the market; and it uses its political authority to manipulate the industry, by arbitrarily picking winners and losers. Most importantly, the FDA inhibits patients’ rights to freely choose treatments and restricts insurers and physicians from doing what they do best: progressing health and saving lives.